BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD US CATHENA 20GX1.25IN STRAIGHT BC

    MDR report key: 20108847 · Received August 30, 2024

    Report

    Report Number
    2243072-2024-00941
    Event Type
    Malfunction
    Date Received
    August 30, 2024
    Date of Event
    August 9, 2024
    Report Date
    October 7, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    UDI-DI
    00382903868636
    PMA / PMN Number
    K220584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON DEVICE HISTORY RECORD REVIEW, NO ABNORMALITY WAS OBSERVED DURING THE PRODUCTION OF THE AFFECTED BATCH. FROM THE RETURNED PHOTO, OBSERVED THAT THE SAFETY MECHANISM WAS NOT ACTIVATED. HOWEVER, UNABLE TO EVALUATE FROM THE PHOTO WHETHER THERE IS SAFETY ACTIVATION COMPONENTS FAILURE/DAMAGE THAT RESULTED IN THE SAFETY ACTIVATION FAILURE SINCE NO SAMPLE RETURNED. AS CURRENT CONTROL, THERE ARE OUTGOING FUNCTIONAL TEST AND IN-PROCESS FUNCTIONAL TEST TO CHECK AND DETECT SAFETY ACTIVATION FAILURE.

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    MATERIAL #:386863; BATCH#:4160443. IT WAS REPORTED BY CUSTOMER THAT THE SAFETY DIDNT' ACTIVATE WHEN IV WAS ADVANCED. VERBATIM: SAFETY DIDNT' ACTIVATE WHEN IV WAS ADVANCED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD US CATHENA 20GX1.25IN STRAIGHT BC SAFETY SHIELD ACTIVATION FAILED IT WAS REPORTED BY CUSTOMER THAT THE SAFETY "DIDN'T" ACTIVATE WHEN IV WAS ADVANCED. VERBATIM: SAFETY DIDNT' ACTIVATE WHEN IV WAS ADVANCED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1910808 BD US CATHENA 20GX1.25IN STRAIGHT BC HYPODERMIC SINGLE LUMEN NEEDLE FOZ BECTON DICKINSON 4160443 00382903868636

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown