BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD US CATHENA 20GX1.25IN STRAIGHT BC

    MDR report key: 20108734 · Received August 30, 2024

    Report

    Report Number
    2243072-2024-00939
    Event Type
    Malfunction
    Date Received
    August 30, 2024
    Date of Event
    August 8, 2024
    Report Date
    October 10, 2024
    Manufacturer
    BD SUZHOU (MDS)
    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 ACTUAL SAMPLE, NO DENT WAS OBSERVED ON THE CANNULA THAT WOULD OBSTRUCT THE MOVEMENT OF THE TIP SHIELD FOR SAFETY ACTIVATION. THERE WAS ALSO NO DAMAGE TO THE V-CLIP AND WASHER, WHICH ARE KEY COMPONENTS FOR THE SAFETY MECHANISM ACTIVATION. THE SAFETY MECHANISM OF THE RETURNED SAMPLE WAS ABLE TO BE MANUALLY ACTIVATED; NO SAFETY ACTIVATION FAILURE WAS OBSERVED. 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 CATHENA SAFETY DIDN'T ACTIVATE. VERBATIM: 18G 1.25" CATHENA SAFETY DIDN'T ACTIVATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD US CATHENA 20GX1.25IN STRAIGHT BC SAFETY SHEILD ACTIVATION FAILURE. IT WAS REPORTED BY CUSTOMER THAT THE CATHENA SAFETY DIDN'T ACTIVATE. VERBATIM: 18G 1.25" CATHENA SAFETY DIDN'T ACTIVATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1597310 BD US CATHENA 20GX1.25IN STRAIGHT BC INTRAVASCULAR ADMINISTRATION SET FOZ BD SUZHOU (MDS) 4160443 00382903868636

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown