BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD US CATHENA 22GX1.00IN STRAIGHT BC

    MDR report key: 21103378 · Received January 8, 2025

    Report

    Report Number
    2243072-2024-01301
    Event Type
    Malfunction
    Date Received
    January 8, 2025
    Date of Event
    December 17, 2024
    Report Date
    January 13, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    UDI-DI
    00382903868612
    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

    NO PHOTOS OR SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION THEREFORE THE FAILURE MODE COULD NOT BE VERIFIED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBERS WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. BASED ON THE QUALITY TEAM'S INVESTIGATION, THE ROOT CAUSE OF THIS INCIDENT CANNOT BE DETERMINED.

    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

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD US CATHENA 22GX1.00IN STRAIGHT BC SAFETY SHIELD ACTIVATION FAILED IT WAS REPORTED BY CUSTOMER THAT WHEN TRYING TO RETRACT THE NEEDLE INTO IT'S SAFETY MODE, IT DID NOT GO INTO SAFETY MODE BUT INSTEAD JUST EXPOSED THE LONG NEEDLE WITHOUT THE SAFETY. VERBATIM: BD CATHENA 22G. SPECIFICALLY, LOT #4124014, EXP. 04/30/27. WHEN TRYING TO RETRACT THE NEEDLE INTO IT'S SAFETY MODE, IT DID NOT GO INTO SAFETY MODE BUT INSTEAD JUST EXPOSED THE LONG NEEDLE WITHOUT THE SAFETY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    883151 BD US CATHENA 22GX1.00IN STRAIGHT BC INTRAVASCULAR CATHETER FOZ BECTON DICKINSON 4124014 00382903868612

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown