BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 18251838 · Received December 1, 2023

    Report

    Report Number
    2647876-2023-00613
    Event Type
    Malfunction
    Date Received
    December 1, 2023
    Date of Event
    October 30, 2023
    Report Date
    December 8, 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
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: CATALOG: 442023. BATCH NO.: 3130646. 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. COMPLAINT IS UNCONFIRMED BASED ON RETENTION SAMPLES AND BATCH HISTORY RECORD REVIEW RESULTS.

    Description of Event or Problem · 0

    REPORT 2 OF 2. IT WAS REPORTED THAT WHEN USING THE BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC), THERE WERE TWO MOLECULAR FALSE POSITIVES. NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " REPORTED 2 MOLECULAR FP WHICH WAS C.TROPICALIS WITH BCID 2. GRAIN STAIN WAS GPB AND CULTURE WAS CORYNEBATERIUM. (2) GVB & GPCCL, CULTURE S CAPITIS & PAENIBACILLUS."

    Description of Event or Problem · 0

    REPORT 2 OF 2. IT WAS REPORTED THAT WHEN USING THE BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC), THERE WERE TWO MOLECULAR FALSE POSITIVES. NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " REPORTED 2 MOLECULAR FP WHICH WAS C.TROPICALIS WITH BCID 2. GRAIN STAIN WAS GPB AND CULTURE WAS CORYNEBATERIUM. (2) GVB & GPCCL, CULTURE S CAPITIS & PAENIBACILLUS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1399543 BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 3130646 00382904420239

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown