BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOG BC WING

    MDR report key: 19669270 · Received July 3, 2024

    Report

    Report Number
    1710034-2024-00687
    Event Type
    Malfunction
    Date Received
    July 3, 2024
    Date of Event
    June 12, 2024
    Report Date
    July 15, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903826339
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 382633 AND LOT NUMBER 4091434. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. BASED ON THE AVAILABLE INFORMATION, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOG BC WING CATHETER TIP IS NOT BEVELED/IS COMING APART. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NURSES ARE ALSO NOTING THAT THE SHEATH DOES NOT APPEAR TO BE BEVELED CAUSING DIFFICULTY IN ADVANCING THE CATHETER INTO THE VEIN WE HAVE A MAJOR SAFETY CONCERN IF THIS SHEATH BECOMES DETACHED WHILE IN THE PATIENT. SO FAR THIS HAS ONLY OCCURRED BEFORE PLACING THE IV SO STAFF JUST GRAB A NEW ONE, BUT IF THIS HAPPENS WHILE INSIDE A PATIENT IT MAY REQUIRE A PROCEDURE TO PROPERLY REMOVE IT SOUNDS LIKE THE SHEATH IS FAILING AND PULLING APART WHEN REMOVING THE CAP

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    901492 BD INSYTE AUTOG BC WING PERIPHERAL IV CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4091434 00382903826339

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown