FIELD CORRECTIVE ACTION (FCA) LISTING FOR NOVEMBER 2022
The list below contains Medical Device’s Field Corrective Action for the month of November 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 |
|
23 Nov 2022 |
ASSURITY & ASSURITY MRI PACEMAKERS |
MDA/FCA/P0135-91376142-2022 |
GD71875822118 |
Abbott is providing the following supplemental information for consideration by clinicians in determining the appropriate course of action for patients: 1. The observed average time to functionality interruption at present is 2.2 years post implant 2. There is a high degree of statistical confidence (95%) that, if a malfunction were to occur, 99% of devices will present functionality interruption at or after 1.44 years (526 days) |
LAW CHING YEE REGULATORY AFFAIRS & COMPLIANCE MANAGER ABBOTT MEDICAL (MALAYSIA) SDN. BHD. |
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1 Nov 2022 |
FIELD SAFETY NOTICE – BD Trucount™ Tubes and Kits [BDB-22-4547] |
BLOOD CELL COUNT IVD KIT AND CONTROLS |
MDA/FCA/P0115-27849456-2022 |
IVDB71229158618 |
BD has confirmed through internal investigation that the labels applied to the BD Trucount™ tubes are becoming detached. Our investigation has identified an adhesive change made at a supplier resulting in the inadequate adhesion. BD is working closely with the supplier to resolve this situation expediently. |
NUR AZALEA BINTI MUHAMMAD ZAINAL ASHIKIN REGULATORY AFFAIRS EXECUTIVE BECTON DICKINSON SDN BHD |
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30 Nov 2022 |
ALPHA ACTIVE PUMP SYSTEM |
MDA/FCA/P0126-73039459-2022 |
GMD95507674218A |
Arjo has investigated customer complaints where mains cables have been damaged accidently or through miss-use (i.e. incorrectly stowed). Although the mains cables on the Alpha Active models listed have been tested to, and comply with IEC60601-1 Medical electrical equipment |
CHONG WAI MUN GENERAL MANAGER BEST CONTACT (M) SDN BHD |
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23 Nov 2022 |
POLARIS MULTIMEDIA |
MDA/FCA/P0121-70251695-2022 |
GA8379220-38340 |
During the course of our global market surveillance activities, we have become aware of a case in which the swivel arm of a display dropped from a ceiling tube, whereby it was held in place by internal cabling only. |
BEATRICE MAH WAN XIN QUALITY AND REGULATORY AFFAIR SPECIALIST DRAEGER MALAYSIA SDN BHD |
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16 Nov 2022 |
B105P/B105M/B125P/ B125M/B155M PATIENT MONITOR |
MDA/FCA/P0125-91190092-2022 |
GC3218021-63208 |
GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use “mmHg” or “kPa” as the unit for CO2 measurement, the displayed value for CO2 measurement can be inaccurate when used in a location that is not at or near sea level. |
LIM SOCK SIANG DIRECTOR GE HEALTHCARE SDN. BHD |
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29 Nov 2022 |
NASAL CANNULA |
MDA/FCA/P0142-30077767-2022 |
GB720571225118 |
Manufacturer have received reports from their side related to disconnection of the tube from the nasal prong section while using the Neonatal Nasal Cannula with curved prongs and tube. |
CHEANG WAI SHAN SALES MANAGER KL MED SUPPLIES (M) SDN BHD |
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25 Nov 2022 |
FLEXITRON |
MDA/FCA/P0139-54017271-2022 |
GC3716519-29208 |
In a rare situation, a reconstruction error may be introduced by Oncentra® Brachy to an existing catheter reconstruction, when using the catheter bending functionality. Erroneously placed reconstruction points may be added that create a double kink in the reconstruction |
BHARAT KUMAR A/L VRAJLAL PREMCHAND DIRECTOR NYPRAX BUSINESS SOLUTIONS |
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25 Nov 2022 |
MICROSELECTRON |
MDA/FCA/P0140-46624467-2022 |
GC55111585618 |
In a rare situation, a reconstruction error may be introduced by Oncentra® Brachy to an existing catheter reconstruction, when using the catheter bending functionality. Erroneously placed reconstruction points may be added that create a double kink in the reconstruction |
BHARAT KUMAR A/L VRAJLAL PREMCHAND DIRECTOR NYPRAX BUSINESS SOLUTIONS |
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22 Nov 2022 |
HEARTSTART HS1 |
MDA/FCA/P0132-45527431-2022 |
GC78411544718 |
Some electrode pads used with the HS1/OnSite/Home AED have been observed to experience gel separation from the foam/tin backing when peeled from the yellow plastic liner. The gel may fold onto itself, resulting in reduced surface area of gel on the pad. |
ZAM ZARINA BINTI MAT ALI Q&R MANAGER PHILIPS MALAYSIA SDN BERHAD |
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23 Nov 2022 |
INGENIA ELITION |
MDA/FCA/P0136-65349717-2022 |
GB179941251719 |
Philips has identified an issue where a specific component failure in the Gradient Coil of where the Affected 3T MR Systems identified in this letter may act as a heat source, with a potential to produce smoke and/or fire. |
ZAM ZARINA BINTI MAT ALI Q&R MANAGER PHILIPS MALAYSIA SDN BERHAD |
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23 Nov 2022 |
AVALON FETAL MONITORS |
MDA/FCA/P0138-97367458-2022 |
GC95268545118 |
Philips has found that the spiral tip of the FSE may break off during use, potentially requiring surgical intervention to remove the broken tip from the patient. |
ZAM ZARINA BINTI MAT ALI Q&R MANAGER PHILIPS MALAYSIA SDN BERHAD |
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9 Nov 2022 |
ELECSYS CA 19-9 |
MDA/FCA/P0123-32422256-2022 |
IVDC53289203518 |
As described in the former versions of MY-FSN-CPS-2020-001, certain Elecsys CA 19-9 lots on cobas e 801 showed in internal investigations and/or customer complaints, an increased rate of non-reproducible elevated results. |
KOH WAI CHIN SENIOR REGULATORY AFFAIRS SPECIALIST ROCHE DIAGNOSTICS (M) SDN. BHD. |
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22 Nov 2022 |
Unacceptable Light Staining & review of negative results - VENTANA PD-L1 (SP142) Assay Specific Lots |
VENTANA PD-L1 (SP142) ASSAY |
MDA/FCA/P0133-31318786-2022 |
IVDC77381365919 |
VENTANA Medical Systems, Inc. (Roche) observed unacceptable, light staining with some VENTANA PD-L1 (SP142) on-market lots, during internal comparison studies. |
KOH WAI CHIN SENIOR REGULATORY AFFAIRS SPECIALIST ROCHE DIAGNOSTICS (M) SDN. BHD. |
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17 Nov 2022 |
Multiple issues concerning VD12A systems Sensis or Sensis Vibe AX057/22/S, AX058/22/S (FSCA), AX059/22/S (FSN)
|
SENSIS VIBE |
MDA/FCA/P0128-86684882-2022 |
GC26491801918 |
Issue 1: “PASSWORD STORE CORRUPTED” error message during system bootup Issue 2: Subsystem crash during examination Issue 3: Dialog Monitor Computer (DMC) application crash while loading a study Issue 4: Software crash due to system internal timeout |
LAM YEN LI HEAD OF QUALITY & TECHNOLOGY SIEMENS HEALTHCARE SDN BHD |
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24 Nov 2022 |
XP051/22/S Potential risk of foot rest detaching from the patient table |
LUMINOS AGILE MAX |
MDA/FCA/P0130-84935675-2022 |
GC74703683318 |
The CSAN is distributed to inform about a preventive measure to exclude any potential risk of patient injury caused by the foot rest detaching from the patient table during an examination. |
LAM YEN LI HEAD OF QUALITY & TECHNOLOGY SIEMENS HEALTHCARE SDN BHD |
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22 Nov 2022 |
Intra-Aortic Balloon Pump (IABP), Short Battery Run Times - Advisory Notice |
ARROW AUTOCAT 2 WAVE INTRA-AORTIC BALLOON PUMP (IABP) SYSTEM |
MDA/FCA/P0134-78584935-2022 |
GD44414701118 |
Arrow International LLC, a subsidiary of Teleflex Incorporated, has initiated a voluntary Field Safety Corrective Action (FSCA) for the product codes referenced above due to a potential issue with short battery run‐times on the affected intra‐aortic balloon pump (IABP) devices. |
CHUAH SIEW SEE REGULATORY AFFAIRS MANAGER TELEFLEX MEDICAL SDN.BHD |
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23 Nov 2022 |
Intra-Aortic Balloon Pump (IABP), Short Battery Run Times
|
AUTOCAT 3 |
MDA/FCA/P0137-69993396-2022 |
GD877091305219 |
Arrow International LLC, a subsidiary of Teleflex Incorporated, has initiated a voluntary Field Safety Corrective Action (FSCA) for the product codes referenced above due to a potential issue with short battery run‐times on the affected intra‐aortic balloon pump (IABP) devices. |
CHUAH SIEW SEE REGULATORY AFFAIRS MANAGER TELEFLEX MEDICAL SDN.BHD |
