BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)
Report
- Report Number
- 2647876-2021-00190
- Event Type
- Malfunction
- Date Received
- October 12, 2021
- Date of Event
- September 14, 2021
- Report Date
- October 25, 2021
- Manufacturer
- BECTON DICKINSON CARIBE LTD.
- Product Code
- MDB
- UDI-DI
- 00382904420239
- PMA / PMN Number
- K113558
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MY
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H6: INVESTIGATION: CUSTOMER REPORTED BLOOD UNDER THE SENSOR. ONE OUT OF THREE PHOTOS RECEIVED SHOWED A SENSOR ADHESION DEFECT. BD WAS UNABLE TO DUPLICATE CUSTOMER¿S EXPERIENCE WITH THE BACTEC PRODUCT. RETENTION SAMPLES WERE VISUALLY INSPECTED WITH SATISFACTORY RESULTS. BATCH/SENSOR HISTORY RECORDS WERE REVIEWED, AND ALL TESTING WERE WITHIN SPECIFICATION FOR PRODUCT RELEASE. BLOOD BACKGROUND WAS PERFORMED WITH SATISFACTORY RESULTS. A COMPLAINT HISTORY REVIEW WAS CONDUCTED AND ONLY THE CURRENT COMPLAINT WAS FOUND RELATING TO THE INCIDENT LOT NUMBER AND THE ¿AS REPORTED¿ DEFECT CODE. SENSOR ADHESION SCRAPE TEST IS PERFORMED TO EACH SENSOR BATCH AS PART OF RELEASE CRITERIA. TINY AIR BUBBLES OBSERVED AT THE BOTTOM AND/OR SIDE OF THE SENSOR IS CAUSED BY THE OUT GASSING OF THE WATER VAPOR DURING THE SENSOR CURING PROCESS. THE PRESENCE OF THESE AIR BUBBLES SHOULD NOT HAVE ANY ADVERSE EFFECT IN SENSOR PERFORMANCE. COMPLAINT IS CONFIRMED BASED ON PHOTOS RECEIVED. THE VISION SYSTEM IS CHALLENGED PRIOR EACH LOT. PRODUCT INSERT WARNINGS AND PRECAUTIONS SECTIONS STATES THAT PRIOR TO USE, EACH VIAL SHOULD BE EXAMINED FOR EVIDENCE OF CONTAMINATION SUCH AS CLOUDINESS, BULGING OR DEPRESSES SEPTUM, OR LEAKAGE. VIALS SHOWING EVIDENCE OF CONTAMINATION SHOULD NOT BE USED. ALSO PRIOR TO USE, THE USER SHOULD EXAMINE THE VIAL FOR EVIDENCE OF DAMAGE OR DETERIORATION. VIALS DISPLAYING TURBIDITY, CONTAMINATION, OR DISCOLORATION (DARKENING) SHOULD NOT BE USED. CAPA #2882676 WAS INITIATED TO FURTHER INVESTIGATE THESE TYPES OF COMPLAINTS AND DETERMINE ANY APPROPRIATE ACTIONS TO REDUCE THEIR OCCURRENCE. A CROSS FUNCTIONAL TEAM CONTINUALLY MONITORS ALL PRODUCT COMPLAINTS FOR TRENDS AND DETERMINES IF ANY ADDITIONAL ACTIONS ARE NECESSARY BEYOND THE CURRENT INVESTIGATIONAL PROCESS.
A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) FLAGGED POSITIVE. CONFIRMATORY GRAM STAN AND CULTURE WERE NEGATIVE. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER NOTICED THAT THE BOTTOM FLUORESCENT SENSOR DYE IS REDDISH IN COLOUR AFTER A FEW TIMES THE BOTTLE PROMPTED AS POSITIVE. WHEN THEY PROCEED WITH GRAM STAIN AND CULTURE, THE RESULTS WAS NOS.
IT WAS REPORTED THAT BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) FLAGGED POSITIVE. CONFIRMATORY GRAM STAN AND CULTURE WERE NEGATIVE. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER NOTICED THAT THE BOTTOM FLUORESCENT SENSOR DYE IS REDDISH IN COLOUR AFTER A FEW TIMES THE BOTTLE PROMPTED AS POSITIVE. WHEN THEY PROCEED WITH GRAM STAIN AND CULTURE, THE RESULTS WAS NOS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1514924 | BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) | SYSTEM, BLOOD CULTURING | MDB | BECTON DICKINSON CARIBE LTD. | 442023 | 1118619 | 00382904420239 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |