BD BACTEC¿ STANDARD ANAEROBIC/F CULTURE VIALS
Report
- Report Number
- 2647876-2021-00193
- Event Type
- Malfunction
- Date Received
- October 13, 2021
- Date of Event
- September 14, 2021
- Report Date
- October 22, 2021
- Manufacturer
- BECTON DICKINSON CARIBE LTD.
- Product Code
- MDB
- UDI-DI
- 00382904421915
- PMA / PMN Number
- K915796
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H6: INVESTIGATION SUMMARY: CUSTOMER REPORTED A FALSE POSITIVE DEFECT. BD WAS UNABLE TO REPRODUCE CUSTOMER EXPERIENCE WITH THE BACTEC PRODUCT. A FALSE POSITIVE RESPONSE WAS NOT OBSERVED WHEN RETENTION SAMPLES WERE TESTED. BATCH HISTORY RECORDS WERE REVIEWED, AND ALL TESTING WERE WITHIN SPECIFICATION FOR PRODUCT RELEASE. 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. 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 BASED ON RETENTION SAMPLES AND BATCH HISTORY RECORD REVIEW. NO CORRECTIVES ACTIONS WERE REQUIRED. A CROSS FUNCTIONAL TEAM CONTINUALLY MONITORS ALL PRODUCT COMPLAINTS FOR TRENDS AND DETERMINES IF ANY ADDITIONAL ACTIONS ARE NECESSARY BEYOND THE CURRENT INVESTIGATION PROCESS.
THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1027294, MEDICAL DEVICE EXPIRATION DATE: 2021-11-30, DEVICE MANUFACTURE DATE: 2021-01-27. MEDICAL DEVICE LOT #: 1061248, MEDICAL DEVICE EXPIRATION DATE: 2021-12-31, DEVICE MANUFACTURE DATE: 2021-03-02. 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 3 BD BACTEC¿ STANDARD ANAEROBIC/F CULTURE VIALS FROM LOT 1027294, AND 2 BOTTLES FROM LOT 1061248 PRODUCED FALSE POSITIVE RESULTS WITH THE BACTEC MEDIA. GRAM STAINS WERE TESTED, WHICH PRODUCED NEGATIVE RESULTS. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED TO CLINICIANS, AND THERE WAS NO REPORT OF ADVERSE PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER HAD 5 FALSE POSITIVES FLAG RECENTLY. NOTHING SEEN IN GRAM STAINS. NO TEMPERATURE ISSUES NOTED. ONLY ONE PATIENT HAD A HIGH WBC. CUSTOMER DOES NOT BELIEVE THE BOTTLES WERE OVERFILLED."
IT WAS REPORTED THAT 3 BD BACTEC¿ STANDARD ANAEROBIC/F CULTURE VIALS FROM LOT 1027294, AND 2 BOTTLES FROM LOT 1061248 PRODUCED FALSE POSITIVE RESULTS WITH THE BACTEC MEDIA. GRAM STAINS WERE TESTED, WHICH PRODUCED NEGATIVE RESULTS. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED TO CLINICIANS, AND THERE WAS NO REPORT OF ADVERSE PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER HAD 5 FALSE POSITIVES FLAG RECENTLY. NOTHING SEEN IN GRAM STAINS. NO TEMPERATURE ISSUES NOTED. ONLY ONE PATIENT HAD A HIGH WBC. CUSTOMER DOES NOT BELIEVE THE BOTTLES WERE OVERFILLED."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1519203 | BD BACTEC¿ STANDARD ANAEROBIC/F CULTURE VIALS | BLOOD CULTURING SYSTEM | MDB | BECTON DICKINSON CARIBE LTD. | 442191 | SEE SECTION H.10. | 00382904421915 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |