BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOG BC

    MDR report key: 20352970 · Received October 2, 2024

    Report

    Report Number
    1710034-2024-01085
    Event Type
    Malfunction
    Date Received
    October 2, 2024
    Date of Event
    September 11, 2024
    Report Date
    October 8, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825349
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 382534 AND LOT NUMBER 4030761. 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. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOG BC NEEDLE DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RN WAS ATTEMPTING TO INSERT IV. IT WAS INTENDED TO START AN IV AND HAVE THE NEEDLE RETRACT INTO THE SAFETY GLIDE. WHEN THE NEEDLE WAS INSERTED AND RETRACTED, THE NEEDLE DID NOT RETRACT INTO THE SAFETY GLIDE. PT HAS PARKINSON'S AND WAS SHAKING, LUCKILY THE LAB TECH WAS ABLE TO GRAB THE EXPOSED NEEDLE AND PLACE IT IN SHARPS BEFORE ANYONE WAS POKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34839 INSYTE AUTOG BC PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4030761 00382903825349

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown