BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 19629323 · Received June 27, 2024

    Report

    Report Number
    2647876-2024-00088
    Event Type
    Injury
    Date Received
    June 27, 2024
    Date of Event
    May 28, 2024
    Report Date
    July 17, 2024
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MDB
    UDI-DI
    00382904420239
    PMA / PMN Number
    K113558
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY CATALOG 442023. BATCH NO. UNKNOWN . CUSTOMER REPORTED AN ALLERGIC REACTION ON HANDS WHEN HANDLING THE BLOOD CULTURE BOTTLES NEITHER PHOTOS NOR RETURNED GOOD SAMPLES WERE RECEIVED. BD WAS NOT ABLE TO PERFORM AN INVESTIGATION TO THE RETENTION SAMPLES SINCE BATCH NUMBER IS UNKNOWN. A COMPLAINT HISTORY REVIEW CANNOT BE CONDUCTED RELATING TO THE INCIDENT LOT NUMBER AND THE ¿AS REPORTED¿ DEFECT CODE SINCE BATCH NUMBER IS UNKNOWN. THE BATCH HISTORY RECORD COULD NOT BE REVIEWED AS THE LOT NUMBER IS UNKNOWN NONETHELESS BATCH HISTORY RECORDS ARE ALWAYS REVIEWED PRIOR TO PRODUCT RELEASE. COMPLAINT IS UNCONFIRMED. NO CORRECTIVES ACTIONS WERE REQUIRED. A CROSS FUNCTIONAL TEAM CONTINUALLY MONITORS ALL PRODUCT COMPLAINTS FOR TRENDS AND DETERMINES IF ANY ADDITIONAL ACTIONS ARE NECESSARY BEYOND THE CURRENT INVESTIGATION PROCESS.

    Additional Manufacturer Narrative · 0

    G5: PMA/510(K)#: K222591. 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 WHEN HANDLING THE BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC), AN INDIVIDUAL CAME INTO CONTACT WITH THE ADHESIVE ON THE LABEL OF THE BLOOD CULTURE BOTTLE AND EXPERIENCED AN ALLERGIC REACTION, RESULTING IN BLISTERS ON THEIR HANDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN HANDLING THE BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC), AN INDIVIDUAL CAME INTO CONTACT WITH THE ADHESIVE ON THE LABEL OF THE BLOOD CULTURE BOTTLE AND EXPERIENCED AN ALLERGIC REACTION, RESULTING IN BLISTERS ON THEIR HANDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2193155 BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. UNKNOWN 00382904420239

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other