BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 19375039 · Received May 22, 2024

    Report

    Report Number
    2647876-2024-00082
    Event Type
    Malfunction
    Date Received
    May 22, 2024
    Date of Event
    April 24, 2024
    Report Date
    September 4, 2024
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MDB
    UDI-DI
    00382904420239
    PMA / PMN Number
    SEE H.10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G5: PMA/510(K)#: K113558, 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

    INVESTIGATION SUMMARY: CUSTOMER REPORTED A MISSING VIAL LABEL. NEITHER PHOTOS NOR RETURNED GOODS SAMPLES WERE RECEIVED. BD WAS UNABLE TO REPRODUCE CUSTOMER EXPERIENCE WITH THE BACTEC PRODUCT. SATISFACTORY RESULTS WERE OBTAINED FROM RETENTION SAMPLES WHEN VISUALLY INSPECTED FOR REPORTED DEFECT (NO VIAL LABEL). 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. A CROSS FUNCTIONAL TEAM CONTINUALLY MONITORS ALL PRODUCT COMPLAINTS FOR TRENDS AND DETERMINES IF ANY ADDITIONAL ACTIONS ARE NECESSARY BEYOND THE CURRENT INVESTIGATIONAL PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) BOTTLES WERE NOT LABELED BEFORE USE. NO PATIENT IMPACT OR INJURY REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) BOTTLES WERE NOT LABELED BEFORE USE. NO PATIENT IMPACT OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1749332 BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) MDB BECTON DICKINSON CARIBE LTD. 3298255 00382904420239

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown