BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17425770 · Received July 31, 2023

    Report

    Report Number
    3008352382-2023-00113
    Event Type
    Malfunction
    Date Received
    July 31, 2023
    Date of Event
    July 12, 2023
    Report Date
    August 22, 2023
    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

    IT HAS BEEN DETERMINED THAT THE MDR MFR # 3008352382-2023-00113 HAS BEEN SUBMITTED IN ERROR. THE EVENT OCCURRED BEFORE USE AND THEREFORE THERE WAS NO REPORT OF SERIOUS INJURY, MEDICAL INTERVENTION, OR REPORTABLE DEVICE MALFUNCTION.

    Additional Manufacturer Narrative · 0

    G5. PMA/510K INFO: 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) THERE WAS A HOLE FOUND AND THE MEDIA WAS LEAKING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN DID THE EVENT OCCUR? BEFORE USE ACCORDING TO THE CUSTOMER'S REPORT, THERE WAS A HOLE AT THE TOP OF THE BOTTLES AND THE MEDIA WAS LEAKING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) THERE WAS A HOLE FOUND AND THE MEDIA WAS LEAKING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN DID THE EVENT OCCUR? -- BEFORE USE. ACCORDING TO THE CUSTOMER'S REPORT, THERE WAS A HOLE AT THE TOP OF THE BOTTLES AND THE MEDIA WAS LEAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653686 BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 2276206 00382904420239

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown