FIELD CORRECTIVE ACTION (FCA) LISTING FOR SEPTEMBER 2022
The list below contains Medical Device’s Field Corrective Action for the month of September 2022. This list provides field corrective action reporting information to MDA by establishment in accordance to requirement stipulated in Section 41, Act 737 and Regulation 6 of Medical Device (Duties and Obligations of Establishment) Regulations 2019.
Field Corrective Action (FCA) is part of a post-marketing risk assessment measure to ensure the continued safe use of medical devices in the Malaysia market. It is a corrective or preventive action in relation to a medical device which may include –
- The return of the medical device to the establishment;
- Modification of the medical device;
- Exchange of the medical device;
- Destruction of medical device; or
- Specific advice on the use of the medical device.
If you have experienced any safety and performance issue with one of the medical devices listed for FCA action, please seek advice from your medical device authorised representative as soon as possible.
|
Date received |
Title of FCA |
Affected Medical Device |
MDA Reference Number |
MDA Registration Number |
Description |
Local Establishment Contact Detail |
|
8 August 2022 |
Field Corrective Action on BinaxNOW Nasopharyngeal Swab Pack |
BINAXNOW RSV CARD |
MDA/FCA/P0005-82380934-2022 |
IVDC21199341118 |
The device was missing the supplementary local label that Medical Device Authority (MDA) requires. The subject label contains the Name, Address, and the contact number of the Authorized Representative, and the MDA Registration Number. |
Farah Syuhaidah binti Ahmad Jahiddin Regulatory Affairs & Quality Assurance Executive Abbott Laboratories (M) Sdn. Bhd. |
|
9 Sept 2022 |
Advisory Regarding the Use of the Device - MitraClip and TriClip Delivery System(s) |
MITRACLIP G4 SYSTEM |
MDA/FCA/P0079-31082378-2022 |
GD6483421-54041 |
This communication is to bring awareness, share the actions Abbott is taking, and emphasize the relevant steps of the Instructions for Use (IFU) to aid in optimal function of the Clip locking mechanism. The increased rate of reports is for clips failing to “Establish Final Arm Angle” (EFAA) and for events of “Clip Opening While Locked” (COWL). |
LAW CHING YEE REGULATORY AFFAIRS & COMPLIANCE MANAGER ABBOTT MEDICAL (MALAYSIA) SDN. BHD. |
|
12 Sept 2022 |
TRICLIP G4 SYSTEM |
MDA/FCA/P0080-53953845-2022 |
GD3978322-100487 |
Abbott has observed an increase in complaints regarding Clip locking malfunctions. This communication is to bring awareness, share the actions Abbott is taking, and emphasize the relevant steps of the Instructions for Use (IFU) to aid in optimal function of the Clip locking mechanism. |
LAW CHING YEE REGULATORY AFFAIRS & COMPLIANCE MANAGER ABBOTT MEDICAL (MALAYSIA) SDN. BHD. |
|
|
12 Sept 2022 |
ALINITY HQ ANALYZER |
MDA/FCA/P0081-79359347-2022 |
IVDB31515121518 |
The Alinity h-series System Control Center (SCC) Application Software Version 4.3 (and below) and the Local User Interface (LUI) Embedded Analyzer Engine (EAE) contain a cybersecurity certificate that expired on 08SEP2022. Whenever the software checks for the cybersecurity certificate expiration date and it detects that it has expired, the SCC and/or LUI becomes nonfunctional. |
VIOLA SUBHASHINI PETERS REGULATORY AFFAIRS & QUALITY ASSURANCE MANAGER ABBOTT LABORATORIES (MALAYSIA) SDN. BHD. |
|
|
28 Sept 2022 |
AQUIOS CL Flow Cytometry System, AQUIOS IMMUNO-TROL, and AQUIOS IMMUNO-TROL Low Cells AQUIOS IMMUNO-TROL Cells (PLG/Tetra) and AQUIOS IMMUNO-TROL Low Cells (PLG/Tetra) |
AQUIOS TETRA-1 PANEL AND AQUIOS TETRA-2 PANEL MONOCLONAL ANTIBODY |
MDA/FCA/P0096-51688064-2022 |
IVDC1382943917 |
Beckman Coulter has identified that AQUIOS CL Flow Cytometry System exhibited Potential Sample Gating (PSG) notifications and intermittent Separation Quotient (SQ) failures on Tetra Combo protocol multiple AQUIOS CL units during verification testing. |
NUR AISHAH BINTI ABD AZIZ RA SPECIALIST BECKMAN COULTER MALAYSIA SDN. BHD. |
|
30 Sept 2022 |
SUBSTRATES (ENZYMATIC COLOUR TEST) |
MDA/FCA/P0098-12073847-2022 |
IVDB54451262818 |
The expiration date on the instrument (2022-09-01) was three (3) months longer than the expiry date on the kit label and the COA (2022-06-01) for the same product lot. The reagent packaging and R1 buffer barcode information were inconsistent. |
NUR AISHAH BINTI ABD AZIZ RA SPECIALIST BECKMAN COULTER MALAYSIA SDN. BHD. |
|
|
30 Sept 2022 |
PHADIA AB IMMUNOCHEMISTRY ALLERGY |
MDA/FCA/P0095-73550218-2022 |
IVDB4145881517 |
Several complaints have been registered due to unusually large mean difference observed for different lots of ImmunoCAP Allergen f76, Allergen component nBos d 4 Alpha-lactalbumin, Milk covered in UKNEQAS assessment 216. No malfunction was found for this issue, and the investigations concluded that the sample 216 from UKNEQAS was a rare type of sample. |
APPHIA EU CHIA HUI SENIOR REGULATORY & QA BIOMARKETING SERVICES (M) SDN BHD |
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|
21 Sept 2022 |
PD-L1 IHC 22C3 PHARMDX |
MDA/FCA/P0077-27336450-2022 |
IVDC9585520-42303 |
Agilent has new data that indicates a shorter cut section storage recommendation for cervical cancer compared to what is currently in the IFU. |
HOW KIAN MING MANAGING DIRECTOR BITA LIFESCIENCE SDN. BHD. |
|
|
28 Sept 2022 |
DILATOR |
MDA/FCA/P0086-60037817-2022 |
GB57135152017 |
On 23 Aug 2022, SADC discovered that they had shipped non-stock orders without their corresponding English print Instruction For Use (IFU) to Malaysia. This is as a result of an error setting in the order processing system in SADC. This covers the non- stock orders being processed from 15 Feb 2022 to 23 Aug 2022. |
CHONG SINN HUEI (CLAIRE) REGULATORY AFFAIRS SPECIALIST COOK ASIA (MALAYSIA) SDN BHD |
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30 Sept 2022 |
FOGARTY ARTERIAL EMBOLECTOMY CATHETER |
MDA/FCA/P0097-94324579-2022 |
GB849043816 |
Edwards Lifesciences has received reports of inability to inflate the balloon or maintain balloon integrity for Fogarty arterial embolectomy catheters packaged in a pouch. |
CHIEW CHEE HOE SR. REGULATORY AFFAIRS SPECIALIST EDWARDS LIFESCIENCES (MALAYSIA) SDN BHD |
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|
13 Sept 2022 |
ON-Q PRODUCTS WITH SILVERSOAKER CATHETERS |
MDA/FCA/P0084-47279672-2022 |
GC194041037018 |
Instructions For Use are an integral part of the device and may need to be consulted for appropriate usage of the devices. The supply of the product is with square filter however IFU packed within is reflecting the diagram of round filter. |
NUR DALILA BINTI UMAR RAQA EXECUTIVE GLOBAL HEALTHCARE LOGISTICS (M) SDN BHD |
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|
24 Sept 2022 |
MINIMED 640G INSULIN PUMP AND ACCESSORIES |
MDA/FCA/P0091-36368856-2022 |
GC23882493217 |
During internal analysis of an unrelated failure, a potential issue was identified whereby, under specific circumstances, the communication between the components of the MiniMed 600 series pump system could be compromised through unauthorized access |
LEE YOUN YOUN REGULATORY AFFAIRS LEAD MEDTRONIC MALAYSIA SDN BHD |
|
|
8 Sept 2022 |
AMARA VIEW MASK |
MDA/FCA/P0046-41737396-2022 |
GB27923225017 |
The affected masks contain magnets which can potentially affect the functioning of certain implanted medical devices, such as metal splinters in the eyes, brain shunts, aneurysm clips, pacemakers, implantable cardioverter defibrillators (ICD), defibrillators, VP shunts, and certain neurostimulators used in and around the neck, or any implanted medical device affected by magnets. |
ZAM ZARINA BINTI MAT ALI Q&R MANAGER PHILIPS MALAYSIA SDN BERHAD |
|
|
8 Sept 2022 |
WISP MASK |
MDA/FCA/P0073-29695618-2022 |
GB23831489317 |
The affected masks contain magnets which can potentially affect the functioning of certain implanted medical devices, such as metal splinters in the eyes, brain shunts, aneurysm clips, pacemakers, implantable cardioverter defibrillators (ICD), defibrillators, VP shunts, and certain neurostimulators used in and around the neck, or any implanted medical device affected by magnets. |
ZAM ZARINA BINTI MAT ALI Q&R MANAGER PHILIPS MALAYSIA SDN BERHAD |
|
|
8 Sept 2022 |
DREAMWEAR FULL FACE MASK |
MDA/FCA/P0075-11148602-2022 |
GB910651134618 |
The affected masks contain magnets which can potentially affect the functioning of certain implanted medical devices, such as metal splinters in the eyes, brain shunts, aneurysm clips, pacemakers, implantable cardioverter defibrillators (ICD), defibrillators, VP shunts, and certain neurostimulators used in and around the neck, or any implanted medical device affected by magnets. |
ZAM ZARINA BINTI MAT ALI Q&R MANAGER PHILIPS MALAYSIA SDN BERHAD |
|
|
8 Sept 2022 |
DREAMWISP NASAL MASK WITH OVER THE NOSE CUSHION |
MDA/FCA/P0076-69785803-2022 |
GB8465320-39381 |
The affected masks contain magnets which can potentially affect the functioning of certain implanted medical devices, such as metal splinters in the eyes, brain shunts, aneurysm clips, pacemakers, implantable cardioverter defibrillators (ICD), defibrillators, VP shunts, and certain neurostimulators used in and around the neck, or any implanted medical device affected by magnets. |
ZAM ZARINA BINTI MAT ALI Q&R MANAGER PHILIPS MALAYSIA SDN BERHAD |
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|
26 Sept 2022 |
Cobas 8000 |
MDA/FCA/P0089-20833573-2022 |
IVDA10967919-27203 |
With the Version 1 of the FSN-RDS-CoreLab-2022-004, we informed about an operational software issue affecting cobas pro/cobas 8000 e 801 analytical units. The issue was detected internally by the manufacturer Hitachi High-Tech Corporation (HHT). |
KOH WAI CHIN SENIOR REGULATORY AFFAIRS SPECIALIST ROCHE DIAGNOSTICS (M) SDN. BHD. |
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29 Sept 2022 |
AUTOMATED URINE CHEMISTRY ANALYZER |
MDA/FCA/P0083-10045584-2022 |
IVDB36827210418 |
Siemens Healthcare Diagnostics has confirmed that two analyte limitations were omitted and nine analyte limitations were incomplete from the Limitation section of the CLINITEK Novus PRO 12 Urinalysis Cassette Instructions for Use (IFU). The limitation information for pH and color are not impacted. |
LAM YEN LI HEAD OF QUALITY & TECHNOLOGY SIEMENS HEALTHCARE SDN BHD |
|
|
21 Sept 2022 |
VITROS IMMUNODIAGNOSTIC PRODUCTS HIV COMBO |
MDA/FCA/P0082-21564970-2022 |
IVDD7178222-90123 |
Ortho received a customer complaint of false negative results generated from VITROS HIV Combo Reagent Pack, Lot 0670, when testing a proficiency sample identified to be reactive for the presence of HIV-1 p24 antigen and absent of antibodies to HIV (p24 antigen positive). |
MENG TSE LEEAU MANAGING DIRECTOR T T MEDICAL MANAGEMENT SDN BHD |
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|
7 Sept 2022 |
22TMMYFSCA02 Therakos CELLEX Photopheresis Procedural Kit Leakage 22TMFSCA16 |
THERAKOS CELLEX PHOTOPHERESIS SYSTEM INSTRUMENT |
MDA/FCA/P0072-22608045-2022 |
GC36053619018 |
There have been several reports of a leak being observed at the connection between the saline spike chamber and the associated tubing for CELLEX Photopheresis Procedural Kit (“Kit”) Lot # K257. |
NG KEE YEAN TRANSMEDIC HEALTHCARE SDN BHD |
