BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17971476 · Received October 19, 2023

    Report

    Report Number
    2647876-2023-00259
    Event Type
    Malfunction
    Date Received
    October 19, 2023
    Date of Event
    September 22, 2023
    Report Date
    August 14, 2025
    Manufacturer
    BD CARIBE, LTD
    Product Code
    MDB
    UDI-DI
    00382904420239
    PMA / PMN Number
    K113558
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G5: PMA/510(K)# K222591. H6. CATALOG: 442023. BATCH NO.: 3102725. CUSTOMER REPORTED A MOLECULAR FALSE POSITIVE RESULT. NEITHER PHOTOS NOR RETURNED GOOD SAMPLES WERE RECEIVED. 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. BATCH HISTORY RECORD REVIEW DID NOT IDENTIFY ANY EVIDENCE FOR WHICH THE CUSTOMER SUBMITTED THE COMPLAINT. A COMPLAINT HISTORY REVIEW WAS CONDUCTED, AND BATCH HAS BEEN PREVIOUSLY INVESTIGATED FOR THE REPORTED DEFECT. NO TREND IDENTIFIED FOR BATCH. COMPLAINT IS UNCONFIRMED BASED ON RETENTION SAMPLES AND BATCH HISTORY RECORD REVIEW RESULTS. H3 OTHER TEXT: SEE H.10.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED: B5. IT WAS REPORTED WHILE USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC), THERE WAS A MOLECULAR FALSE POSITIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT. THIS SUPPLEMENTAL MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF RECORDS DATING APRIL 2023¿2025, UNDER CAPA 11910483.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) THAT THERE WAS A MOLECULAR FALSE POSITIVE FOR C. TROPICALIS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER RECEIVED MOLECULAR FP FOR C. TROPICALIS AND STAPH EPI FROM LOT #3102725. AFTER FURTHER INVESTIGATION, CUSTOMER IS NOT ABLE TO CONFIRM IF PATIENT CARE WAS CHANGED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC), THERE WAS A MOLECULAR FALSE POSITIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538514 BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BD CARIBE, LTD 3102725 00382904420239

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown