BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC)
Report
- Report Number
- 2647876-2022-00146
- Event Type
- Malfunction
- Date Received
- May 25, 2022
- Date of Event
- April 21, 2022
- Report Date
- August 8, 2022
- Manufacturer
- BECTON DICKINSON CARIBE LTD.
- Product Code
- MDB
- UDI-DI
- 00382904420215
- PMA / PMN Number
- K123903
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2013106. MEDICAL DEVICE EXPIRATION DATE: 31-OCT-2022. DEVICE MANUFACTURE DATE: 13-JAN-2022. MEDICAL DEVICE LOT #: 1355718. MEDICAL DEVICE EXPIRATION DATE: 31-OCT-2022. DEVICE MANUFACTURE DATE: 21-DEC-2021. MEDICAL DEVICE LOT #: 1342221. MEDICAL DEVICE EXPIRATION DATE: 30-SEP-2022. DEVICE MANUFACTURE DATE: 08-DEC-2021. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
H.6 INVESTIGATION SUMMARY: CATALOG 442021 BATCH NO. 2013106 & 1355718 CUSTOMER REPORTED A FALSE POSITIVE DEFECT. NEITHER PHOTOS NOR RETURNED GOOD SAMPLES WERE RECEIVED. 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. PLOT/LOG FILE REVIEW: OVERALL THESE WERE HIGHLY ATYPICAL PLOTS. 2 / 15 EVALUABLE PLOTS SHOWED COMMON FALSE POSITIVE TYPES (449275620040, 449253317425). THE SIGNALS TENDED TO LOOK A LITTLE NOISY, WHICH IS TYPICALLY ASSOCIATE WITH PHYSICAL OR ENVIRONMENTAL EXTERNAL DISTURBANCES. PLOT EVALUATION WAS INCONCLUSIVE. THE TWO BARCODES MENTIONED SHOWED FALSE POSITIVE PLOT DID NOT REVEAL ANY UNDERLYING CAUSE. THE REMAINING 13 WERE EITHER UNEVALUABLE (DUE TO PLOT COMPRESSION) OR INCONCLUSIVE. 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. CATALOG 442021 BATCH NO. 1342221 CUSTOMER REPORTED A FALSE POSITIVE DEFECT. NEITHER PHOTOS NOR RETURNED GOOD SAMPLES WERE RECEIVED. 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 BATCH HAS BEEN PREVIOUSLY INVESTIGATED FOR THE REPORTED DEFECT. NO TREND IDENTIFIED. 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. PLOT/LOG FILE REVIEW: OVERALL THESE WERE HIGHLY ATYPICAL PLOTS. 2 / 15 EVALUABLE PLOTS SHOWED COMMON FALSE POSITIVE TYPES (449275620040, 449253317425). THE SIGNALS TENDED TO LOOK A LITTLE NOISY, WHICH IS TYPICALLY ASSOCIATE WITH PHYSICAL OR ENVIRONMENTAL EXTERNAL DISTURBANCES. PLOT EVALUATION WAS INCONCLUSIVE. THE TWO BARCODES MENTIONED SHOWED FALSE POSITIVE PLOT DID NOT REVEAL ANY UNDERLYING CAUSE. THE REMAINING 13 WERE EITHER UNEVALUABLE (DUE TO PLOT COMPRESSION) OR INCONCLUSIVE. 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.
IT WAS REPORTED THAT 1 BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC) EACH FROM LOTS 2013106, 1355718, AND 13422221 PRODUCED FALSE POSITIVE RESULTS. THERE WAS NO INDICATION OF CONFIRMATORY TESTING, OR THAT RESULTS WERE REPORTED TO CLINICIANS. THERE WAS ALSO NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FALSE POSITIVES WITH USE OF BACTEC LYTIC/10 ANAER/F VIALS LOTS 2013106, 1355718, AND 13422221."
IT WAS REPORTED THAT 1 BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC) EACH FROM LOTS 2013106, 1355718, AND 13422221 PRODUCED FALSE POSITIVE RESULTS. THERE WAS NO INDICATION OF CONFIRMATORY TESTING, OR THAT RESULTS WERE REPORTED TO CLINICIANS. THERE WAS ALSO NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FALSE POSITIVES WITH USE OF BACTEC LYTIC/10 ANAER/F VIALS LOTS 2013106, 1355718, AND 13422221."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1697628 | BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC) | SYSTEM, BLOOD CULTURING | MDB | BECTON DICKINSON CARIBE LTD. | 442021 | SEE SECTION H10 | 00382904420215 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |