BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD WINGED

    MDR report key: 21473222 · Received February 26, 2025

    Report

    Report Number
    1710034-2025-00323
    Event Type
    Malfunction
    Date Received
    February 26, 2025
    Date of Event
    February 13, 2025
    Report Date
    June 16, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903819232
    PMA / PMN Number
    UNK
    Removal / Correction Number
    MDS-25-5274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: THE COMPLAINT OF NEEDLE RETRACTION FAILURE COULD NOT BE CONFIRMED FROM THE REPRESENTATIVE 22G INSYTE AUTOGUARD UNITS THAT WERE RECEIVED FROM LOT 4282308. A FUNCTIONAL TEST SHOWED THAT EACH NEEDLE FULLY RETRACTED WHEN THE SAFETY MECHANISM WAS ACTIVATED. ALTHOUGH THE REPRESENTATIVE SAMPLES AND MANUFACTURING RECORDS DO NOT SUPPORT THE COMPLAINANT¿S DESCRIPTION OF THE REPORTED EVENT, THE COMPLAINT HAS BEEN DOCUMENTED AND WILL CONTINUE TO BE MONITORED AS PART OF ONGOING EFFORTS TO IDENTIFY POTENTIAL MANUFACTURING RELATED ISSUES. A REVIEW OF MANUFACTURING RECORDS WAS PERFORMED AND THERE WERE NO ISSUES DURING THE PRODUCTION OF THIS BATCH. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION OF FA#.

    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 AUTOGUARD WINGED NEEDLE DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IN ADDITION, THESE CATHETERS PRESENT A PROBLEM OF MANDREL RETRACTION, WHICH DOES NOT RETRACT AUTOMATICALLY WHEN THE BUTTON IS PRESSED (OR MORE SLOWLY), WHICH CAUSES A RISK OF NEEDLESTICK AND THEREFORE OF A BLOOD EXPOSURE ACCIDENT. CLINICAL CONSEQUENCE: THE DEFECT HAS LED TO MISSED PVP PLACEMENTS WITH THE NEED TO RE-PUNCTURE PATIENTS. CONSIDERABLE INCREASE IN THE RISK OF NEEDLESTICK AND THEREFORE OF BLOOD EXPOSURE ACCIDENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540462 BD INSYTE AUTOGUARD WINGED PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4282308 00382903819232

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown