BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)

    MDR report key: 14628482 · Received June 7, 2022

    Report

    Report Number
    2647876-2022-00154
    Event Type
    Malfunction
    Date Received
    June 7, 2022
    Date of Event
    May 16, 2022
    Report Date
    July 1, 2022
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MDB
    UDI-DI
    00382904420239
    PMA / PMN Number
    K113558
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1252596, MEDICAL DEVICE EXPIRATION DATE: 2022-06-30, DEVICE MANUFACTURE DATE: 2021-09-09. MEDICAL DEVICE LOT #: 1252583, MEDICAL DEVICE EXPIRATION DATE: 2022-06-30, DEVICE MANUFACTURE DATE: 2021-09-09. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    CHANGE IN REPORTABILITY. THIS COMPLAINT IS NO LONGER REPORTABLE. COMPLAINT WAS DETERMINED TO BE QC FAILURE ¿ ATCC STRAIN.

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: CUSTOMER REPORTED A PERFORMANCE ISSUE WHILE USING BACTEC PRODUCT. THREE PHOTOS OF BOTTLES WERE RECEIVED. ONE OF THE PHOTOS SHOWED THE SENOR AREA OF THE BOTTLE. RETENTION SAMPLES COULD NOT BE VISUALLY INSPECTED/ TESTED FOR REPORTED DEFECT. BATCH HISTORY RECORD REVIEW WAS USED FOR THIS INVESTIGATION. BATCH AND SENSOR HISTORY RECORDS REVIEW DID NOT IDENTIFY ANY EVIDENCE FOR WHICH THE CUSTOMER SUBMITTED THE COMPLAINT. 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. COMPLAINT IS UNCONFIRMED BASED ON BATCH RECORD REVIEW RESULTS. QUALITY CONTROL CERTIFICATES LIST TEST ORGANISM, INCLUDING ATCC¿ CULTURE SPECIFIED IN THE CLSI STANDARD M22, QUALITY CONTROL FOR COMMERCIALLY PREPARED MICROBIOLOGICAL CULTURE MEDIA FOR EXPECTED ATCC PERFORMANCE. NO CORRECTIVE 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. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) HAS BEEN FOUND EXPERIENCING PERFORMANCE ISSUES. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THERE WAS A LOW PERFORMANCE ON MEDIA 442023 WITH LOTS 1252596 AND 1252583. THE LOT# 1252596, TOOK 2.8 DAYS FOR POSITIVE DETECTION AND GAVE A 47 CFU COUNT AND LOT# 1252583, TOOK 2.2 DAYS FOR POSITIVE DETECTION AND GAVE A 39 CFU COUNT. THEY HAD EXPECTED TO BE LIKE LOT# 2033621, TOOK 1.9 DAYS FOR POSITIVE DETECTION AND GAVE A 7 CFU COUNT.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) HAS BEEN FOUND EXPERIENCING PERFORMANCE ISSUES. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THERE WAS A LOW PERFORMANCE ON MEDIA 442023 WITH LOTS 1252596 AND 1252583. THE LOT# 1252596, TOOK 2.8 DAYS FOR POSITIVE DETECTION AND GAVE A 47 CFU COUNT AND LOT# 1252583, TOOK 2.2 DAYS FOR POSITIVE DETECTION AND GAVE A 39 CFU COUNT. THEY HAD EXPECTED TO BE LIKE LOT# 2033621, TOOK 1.9 DAYS FOR POSITIVE DETECTION AND GAVE A 7 CFU COUNT.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) HAS BEEN FOUND EXPERIENCING PERFORMANCE ISSUES. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THERE WAS A LOW PERFORMANCE ON MEDIA 442023 WITH LOTS 1252596 AND 1252583. THE LOT# 1252596, TOOK 2.8 DAYS FOR POSITIVE DETECTION AND GAVE A 47 CFU COUNT AND LOT# 1252583, TOOK 2.2 DAYS FOR POSITIVE DETECTION AND GAVE A 39 CFU COUNT. THEY HAD EXPECTED TO BE LIKE LOT# 2033621, TOOK 1.9 DAYS FOR POSITIVE DETECTION AND GAVE A 7 CFU COUNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2197448 BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 442023 SEE H.10 00382904420239

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown