BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC PLUS AEROBIC/F CULTURE VIALS (PLASTIC)

    MDR report key: 12139351 · Received July 8, 2021

    Report

    Report Number
    3008352382-2021-00176
    Event Type
    Malfunction
    Date Received
    July 8, 2021
    Date of Event
    May 27, 2021
    Report Date
    July 8, 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
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 #: 1039608. MEDICAL DEVICE EXPIRATION DATE: 2021-11-30. DEVICE MANUFACTURE DATE: 2021-02-08. MEDICAL DEVICE LOT #: 1061232. MEDICAL DEVICE EXPIRATION DATE: 2021-12-31. DEVICE MANUFACTURE DATE: 2021-03-02. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. A GRAM STAIN WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. THE CUSTOMER STATED RESULTS WERE REPORTED OUT, BUT THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IT WAS REPORTED THAT CONTAMINATION. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1031100 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