BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD US CATHENA 20GX1.25IN STRAIGHT BC

    MDR report key: 19973639 · Received August 13, 2024

    Report

    Report Number
    2243072-2024-00893
    Event Type
    Malfunction
    Date Received
    August 13, 2024
    Date of Event
    July 23, 2024
    Report Date
    August 20, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    UDI-DI
    00382903868636
    PMA / PMN Number
    K220584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. AS CURRENT CONTROL, THERE ARE OUTGOING FUNCTIONAL TEST AND IN-PROCESS FUNCTIONAL TEST TO CHECK AND DETECT SAFETY ACTIVATION FAILURE. AS NO PHOTO AND SAMPLE IS RETURNED FOR EVALUATION, ROOT CAUSE COULD NOT BE ESTABLISHED.

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED. B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.

    Description of Event or Problem · 0

    MATERIAL # 386863; BATCH # 4082702. IT WAS REPORTED BY CUSTOMER THAT WHITE SAFETY MECHANISM STUCK IN HOUSING, DIDN'T COVER NEEDLE TIP WHEN CATHETER ADVANCED. VERBATIM: WHITE SAFETY MECHANISM STUCK IN HOUSING...DIDN'T COVER NEEDLE TIP WHEN CATHETER ADVANCED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD US CATHENA 20GX1.25IN STRAIGHT BC SAFETY MECHANISM DOES NOT FULLY COVER NEEDLE. IT WAS REPORTED BY CUSTOMER THAT WHITE SAFETY MECHANISM STUCK IN HOUSING, DIDN'T COVER NEEDLE TIP WHEN CATHETER ADVANCED. VERBATIM: WHITE SAFETY MECHANISM STUCK IN HOUSING, DIDN'T COVER NEEDLE TIP WHEN CATHETER ADVANCED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1201011 BD US CATHENA 20GX1.25IN STRAIGHT BC INTRAVASCULAR CATHETER FOZ BECTON DICKINSON 4082702 00382903868636

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown