BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17631900 · Received August 28, 2023

    Report

    Report Number
    2647876-2023-00108
    Event Type
    Malfunction
    Date Received
    August 28, 2023
    Date of Event
    August 21, 2023
    Report Date
    December 22, 2023
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MDB
    UDI-DI
    00382904420239
    PMA / PMN Number
    K113558
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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: 19-DEC-2023. H.6. INVESTIGATION SUMMARY: CATALOG: 442023. BATCH NO.: 3090022. 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/RETURNED 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. 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. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    E.6 INITIAL REPORTER E-MAIL: (B)(6). G.6 PMA / 510(K)#K113558, K22259. H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, 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) THAT THERE WAS MOLECULAR POSITIVE IN ONE BOTTLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ISSUE PRODUCT - MOLECULAR FP.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) THAT THERE WAS MOLECULAR POSITIVE IN ONE BOTTLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ISSUE PRODUCT - MOLECULAR FP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316811 BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 3090022 00382904420239

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown