BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOG BC WING

    MDR report key: 20605928 · Received November 5, 2024

    Report

    Report Number
    1710034-2024-01261
    Event Type
    Malfunction
    Date Received
    November 5, 2024
    Date of Event
    October 15, 2024
    Report Date
    November 11, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903826124
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. D. THE LOT NUMBER 4012528 PROVIDED CANNOT BE VERIFIED IN ASSOCIATION WITH THE REPORTED MATERIAL NUMBER.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: AS NO PHYSICAL SAMPLE, PICTURE SAMPLE, OR LOT NUMBER WAS PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. BASED ON THE LIMITED INVESTIGATION RESULTS, A ROOT CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOG BC WING BLOOD LEAKED PAST THE BLOOD CONTROL FEATURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DESCRIBE THE EVENT OR PROBLEM: UPON RETRACTING THE NEEDLE FROM A 24 G IV AFTER PLACEMENT, THE BLOOD FLOWS OUT OF THE CATHETER THAT IS LEFT IN PLACE. IT ALSO HAPPENED TWICE ON A DIFFERENT DAY. THE IV HAS THE SAME LOT NUMBERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1727898 BD INSYTE AUTOG BC WING PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. UNKNOWN 00382903826124

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown