FIELD CORRECTIVE ACTION LISTING FOR NOVEMBER 2023
The list below contains Medical Device’s Field Corrective Action for the month of November 2023. 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.
|
No |
Date Received |
Title of FCA |
Affected Medical Device |
MDA Reference Number |
MDA Registration Number |
Description |
Local Establishment Contact Detail |
|
1 |
30 Nov 2023 |
TactiSys Quartz Missing Instructions for Use (IFU) (FA-Q323-EP-1) |
TACTISYS QUARTZ EQUIPMENT AND ACCESSORIES |
MDA/FCA/P0605-76449806-2023 |
GC24898879318 |
Abbott is notifying customer that the Instruction For Use (IFU) insert was not included in the packaging for TactiSys Quartz equipment (Model PN-004 400) part number 600075377 (for Malaysia). |
LAW CHING YEE REGULATORY AFFAIRS MANAGER ABBOTT MEDICAL (MALAYSIA) SDN. BHD. |
|
2 |
1 Dec 2023 |
COMBIDYN® PVC TUBING |
MDA/FCA/P0602-10271596-2023 |
GB18962527718 |
With two customer complaints (BfArM Ref. no. 04114/21 and 28849/22) leaks due to stress cracks in the housing or Luer adapter from multidirectional stopcocks or pressure tubes were reported. In both cases, the root cause analysis revealed probable contact with disinfectants. |
QUEK LANG FAH HEAD OF REGULATORY AFFAIRS B. BRAUN MEDICAL INDUSTRIES SDN. BHD. |
|
|
3 |
30 Nov 2023 |
EMBLEM S-ICD Temporary Loss of Beat Detection: Advisory Correction |
EMBLEM S-ICD SYSTEM |
MDA/FCA/P0599-99278135-2023 |
GD51274167517 |
Boston Scientific received a complaint reported on the EMBLEM SICD Model A219 in January 2022 where the device was temporarily without the ability to deliver therapy. Analysis of the complaint-related device showed that there was a scheduled impedance measurement that occurred at the same time a LATITUDE transmission occurred. |
NOR SYAWALIA BINTI MOHD NOR REGULATORY AFFAIRS ASSOCIATE BOSTON SCIENTIFIC (MALAYSIA) SDN BHD |
|
4 |
15 Dec 2023 |
Product Urgent Safety Alert -Preventative Action Captus® 4000e Spring Arm Failure. |
THYROID UPTAKE SYSTEM |
MDA/FCA/P0616-33062316-2023 |
GB61770792018 |
The failures are the result of a broken tension bolt inside the spring arm. A break in the tension bolt can cause the collimator to fall downward to its lowest point of travel, which is approximately 25 inches (63.5 cm) from the ground. |
NURULAIDA AFIZA BINTI ABDUL KADIR REGULATORY ADMIN H&A MEDICAL SUPPLY SDN BHD |
|
5 |
6 Dec 2023 |
Notis Tindakan Di Lapangan Untuk HistoCore Pegasus dan HistoCore Pegasus Plus |
Tissue Processor |
MDA/FCA/P0608-21272431-2023 |
IVDA8128721-79162 |
To avoid tissue damage which will lead to inconclusive report |
KOH SEOK FERN CUSTOMER SERVICE HISTOCENTER (M) SDN BHD |
|
6 |
23 Nov 2023 |
FA1367 MRI Labeling for the SynchroMed TM II Infusion System |
SYNCHROMED II PROGRAMMABLE PUMP SYSTEM AND ACCESSORIES |
MDA/FCA/P0600-91534905-2023 |
GD6185822-96376 |
The MRI Guidelines Instructions for Use for Medtronic Model 8637 Implantable Infusion Systems (MRI Guidelines) indicate that during normal operations, the magnetic field of the MRI scanner will temporarily stop the rotor of the SynchroMed II pump motor and suspend drug infusion for the duration of the MRI exposure. |
CHOW SOON YEE REGULATORY AFFAIRS LEAD MEDTRONIC MALAYSIA SDN BHD |
|
7 |
23 Nov 2023 |
OLYMPUS TJF-Q190V DUODENOSCOPE • Required Duodenoscope Inspection
|
EVIS EXERA III DUODENOVIDEOSCOPE TJF-Q190V |
MDA/FCA/P0598-62110479-2023 |
GB4632321-70352 |
This Field Safety Notice is initiated after becoming aware of recent reports of infections and positive cultures. |
YEOH SEO CHING, SHELLY MANAGER, QUALITY ASSURANCE & REGULATORY AFFAIRS OLYMPUS (MALAYSIA) SDN. BHD. |
|
8 |
7 Dec 2023 |
Reminding to follow the instructions in the LTF-S190-5 Reprocessing Manual. |
VISERA ELITE SYSTEM |
MDA/FCA/P0610-56855582-2023 |
GB3798579516 |
This Field Safety Notice is initiated after Olympus observe deviations from the reprocessing steps detailed in the respective Reprocessing Manual Instructions during an evaluation. These steps are required for the proper reprocessing of these videoscopes. |
YEOH SEO CHING, SHELLY MANAGER, QUALITY ASSURANCE & REGULATORY AFFAIRS OLYMPUS (MALAYSIA) SDN. BHD. |
|
9 |
24 Nov 2023 |
Trilogy Evo and Trilogy Evo O2 Ventilators Instructions for Use |
TRILOGY EVO |
MDA/FCA/P0601-31566509-2023 |
GC2627520-39891 |
Philips Respironics found during an internal review that the Evo product listed above had errors in their Instructions for Use (IFUs). The following contraindications were either not documented or were recorded in an incorrect section of the IFUs. -The AVAPS feature is contraindicated for patients less than 10 kg. -The AVAPS-AE therapy mode is contraindicated for invasive use and patients less than 10 kg. |
ZAM ZARINA BINTI MAT AIL QUALITY & REGULATORY MANAGER PHILIPS MALAYSIA SDN BERHAD |
|
10 |
7 Dec 2023 |
SPECTRAL CT |
MDA/FCA/P0609-12526107-2023 |
GC6307722-96412 |
A defect in Cone Beam Artifact-Correction (CBAC) algorithm when using 64 slice collimation can result in motion related artifacts. |
ZAM ZARINA BINTI MAT AIL QUALITY & REGULATORY MANAGER PHILIPS MALAYSIA SDN BERHAD |
|
|
11 |
29 Nov 2023 |
FSN IM00035 DEFIGARD Touch 7 - Electrode Fault, Defibrillation not function |
DEFIGARD TOUCH 7 |
MDA/FCA/P0603-14873747-2023 |
GC9551022-105940 |
Rare cases of ECG malfunction that also has an effect on the measurement of patient impedance by the defibrillation electrodes have been reported. In this case, DEFIGARD Touch-7 incorrectly reports an electrode fault and defibrillation no longer functions. |
LIM THIAM HONG DIRECTOR SCHILLER ASIA PACIFIC SDN. BHD. |
|
12 |
29 Nov 2023 |
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS |
MDA/FCA/P0604-45981951-2023 |
IVDD4213821-64864 |
Ortho Clinical Diagnostics (QuidelOrtho™) detected an increase in complaints and performed an investigation which confirmed that customers using the lots of VITROS Anti-HBs Reagent Pack/Calibrators listed above may experience an increase in calibration failures or an increase in imprecision for the negative quality control and patient samples if a successful calibration is performed. QuidelOrtho also received one customer complaint regarding a falsely elevated result which was generated by an affected lot. |
MENG TSE LEEAU MANAGING DIRECTOR T T MEDICAL MANAGEMENT SDN BHD |
|
|
13 |
8 Dec 2023 |
WELCH ALLYN Q-STRESS CARDIAC STRESS TESTING SYSTEM |
MDA/FCA/P0611-38407940-2023 |
GB7445020-43257 |
Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Q- Stress and XScribe Cardiac Stress Testing Systems (Q-Stress version 6 or higher and XScribe version 6 or higher) due to a potential change in the QRS amplitude identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled. |
WANG KAIYE SENIOR MANAGER WELCH ALLYN MALAYSIA SDN BHD |