BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS
Report
- Report Number
- 2647876-2022-00017
- Event Type
- Malfunction
- Date Received
- February 1, 2022
- Date of Event
- January 17, 2022
- Report Date
- March 7, 2022
- Manufacturer
- BECTON DICKINSON CARIBE LTD.
- Product Code
- MDB
- PMA / PMN Number
- SEE H.10
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FI
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. PMA/510(K)#: K970512 / K970333. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.
THE FOLLOWING INFORMATION HAS BEEN ADDED: MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT#: 1139295. D.4. MEDICAL DEVICE EXPIRATION DATE: 2022-02-28. H.4. DEVICE MANUFACTURE DATE: 2021-05-19. D.4. MEDICAL DEVICE LOT#: 1055279. D.4. MEDICAL DEVICE EXPIRATION DATE: 2021-12-31. H.4. DEVICE MANUFACTURE DATE: 2021-02-24. D.4. MEDICAL DEVICE LOT#: 1034351. D.4. MEDICAL DEVICE EXPIRATION DATE: 2021-11-30. H.4. DEVICE MANUFACTURE DATE: 2021-02-03.
H6: INVESTIGATION SUMMARY: CUSTOMER REPORTED A FALSE POSITIVE AND PERFORMANCE ISSUE. UPON FURTHER EVALUATION IT WAS NOTICED THAT COMPLAINT RECEIVED WAS FROM A PRODUCT ALREADY EXPIRED. 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. THE BATCH HISTORY RECORD COULD NOT BE REVIEWED AS THE LOTS ARE EXPIRED, NONETHELESS BATCH HISTORY RECORDS ARE ALWAYS REVIEWED PRIOR TO PRODUCT RELEASE. NO INVESTIGATION CAN BE CONDUCTED TO THE RETENTION SAMPLES SINCE THE PRODUCT IS ALREADY EXPIRED. USERS ARE CAUTIONED IN THE PACKAGE INSERT UNDER LIMITATION OF THE PROCEDURE: A GRAM-STAINED SMEAR FROM CULTURE MEDIUM MAY CONTAIN SMALL NUMBER OF NON-VIABLE ORGANISMS DERIVED FROM MEDIA CONSTITUENTS, STAINING REAGENTS, IMMERSION OIL, GLASS SLIDE AND SPECIMENS USED FOR INOCULATION. THERE ARE MANY FACTORS THAT CAN INFLUENCE THE FALSE POSITIVE RATE, INCLUDING BLOOD VOLUME, BLOOD CELL COUNTS, ENVIRONMENTAL FACTORS, AND MEDIA LOT TO LOT VARIATIONS. COMPLAINT IS UNCONFIRMED.
IT HAS BEEN REPORTED THAT THE BD BACTEC¿ MYCO/F LYTIC CULTURE VIAL HAS BEEN FOUND PRODUCING A FALSE POSITIVE RESULT. THERE WAS NO REPORT OF CONFIRMATORY TESTING. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: CUSTOMER INFORMED THAT BLOOD IS DRYING TO THE VIAL WALLS AND THIS IS CAUSING FALSE POSITIVE RESULT.
IT HAS BEEN REPORTED THAT THE BD BACTEC¿ MYCO/F LYTIC CULTURE VIAL HAS BEEN FOUND PRODUCING A FALSE POSITIVE RESULT. THERE WAS NO REPORT OF CONFIRMATORY TESTING. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: CUSTOMER INFORMED THAT BLOOD IS DRYING TO THE VIAL WALLS AND THIS IS CAUSING FALSE POSITIVE RESULT.
IT HAS BEEN REPORTED THAT THE BD BACTEC¿ MYCO/F LYTIC CULTURE VIAL HAS BEEN FOUND PRODUCING A FALSE POSITIVE RESULT. THERE WAS NO REPORT OF CONFIRMATORY TESTING. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: CUSTOMER INFORMED THAT BLOOD IS DRYING TO THE VIAL WALLS AND THIS IS CAUSING FALSE POSITIVE RESULT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1446221 | BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS | SYSTEM, BLOOD CULTURING | MDB | BECTON DICKINSON CARIBE LTD. | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |