BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 18185261 · Received November 21, 2023

    Report

    Report Number
    2647876-2023-00541
    Event Type
    Malfunction
    Date Received
    November 21, 2023
    Date of Event
    October 26, 2023
    Report Date
    January 8, 2024
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MDB
    UDI-DI
    00382904420239
    PMA / PMN Number
    K113558
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION. D10: DEVICE AVAILABLE FOR EVALUATION: YES D10: RETURNED TO MANUFACTURER ON: 12-DEC-2023 H.6. INVESTIGATION SUMMARY: CATALOG: 442023 BATCH NO.: 3151331 CUSTOMER REPORTED A MOLECULAR FALSE POSITIVE RESULT. BD WAS UNABLE TO REPRODUCE THE CUSTOMER¿S EXPERIENCE WITH THE BACTEC PRODUCT BASED ON OUR INTERNAL PROCEDURES AND THE INTENDED USE OF THE PRODUCT. RETENTION SAMPLES WERE VISUALLY INSPECTED, TESTED FOR VIABLE CONTAMINATION BY SUB-CULTURING ON TSA, CHOCOLATE, SABOURAUD AND SCHAEDLER AGARS PLATES, VOLTAGE OUTPUT AND GRAM STAIN. ALL RESULTS WERE SATISFACTORY. RETURNED GOOD SAMPLE WAS VISUALLY INSPECTED AND TESTED FOR VOLTAGE OUTPUT AND GRAM STAIN. ALL RESULTS WERE SATISFACTORY. BATCH HISTORY RECORD 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 RETENTION/RETURNED SAMPLES AND BATCH HISTORY RECORD REVIEW RESULTS.

    Additional Manufacturer Narrative · 0

    G5: PMA/510(K)#: K222591. H.3. 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 THE BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC), THERE WAS ONE MOLECULAR FALSE POSITIVE FOR C. TROPICALIS. NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER:"CUSTOMER IS REPORTING MOLECULAR FALSE POSITIVE FOR PRODUCT 442023 LOT NO. 3151331. 1 MOLECULAR PATIENT FALSE POSITIVE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC), THERE WAS ONE MOLECULAR FALSE POSITIVE FOR C. TROPICALIS. NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER IS REPORTING MOLECULAR FALSE POSITIVE FOR PRODUCT 442023, LOT NO. 3151331. 1 MOLECULAR PATIENT FALSE POSITIVE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836830 BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 3151331 00382904420239

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown