BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD WINGED

    MDR report key: 21022126 · Received December 26, 2024

    Report

    Report Number
    1710034-2024-01537
    Event Type
    Malfunction
    Date Received
    December 26, 2024
    Date of Event
    December 9, 2024
    Report Date
    March 6, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903819232
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: THE COMPLAINT OF SLOW NEEDLE RETRACTION COULD NOT BE CONFIRMED FROM THE RETURNED SAMPLE. ONE INSYTE AUTOGUARD NEEDLE FROM LOT 4222720 WAS PROVIDED FOR INVESTIGATION. THE NEEDLE WAS RECEIVED FULLY RETRACTED AND WITH EVIDENCE OF USE. A FUNCTIONAL TEST SHOWED THAT THE NEEDLE RETRACTED WITHIN SPECIFICATION. THE CONDITION OF THE RETURNED DEVICE MAY PREVENT CONFIRMATION OF THE REPORTED ISSUE. ONCE THE NEEDLE FULLY RETRACTS, THE REPORTED ISSUE MAY NOT BE POSSIBLE TO REPLICATE. ALTHOUGH THE COMPLAINT COULD NOT BE CONFIRMED, A TREND WAS IDENTIFIED FOR NEEDLE RETRACTION SLOW COMPLAINTS AND A CAPA WAS OPENED TO ADDRESS THIS ISSUE. THIS COMPLAINT TYPE AND CORRECTIVE ACTION WILL CONTINUE TO BE MONITORED FOR EFFECTIVENESS. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOGUARD WINGED NEEDLE RETRACTION ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: DIFFICULTY RETRACTING THE CANULA. RECURRENT PROBLEMS WITH SEVERAL CAREGIVERS. LETTER ATTACHED. PROBLEM RETRACTING THE CANULA. PRESSED 2 TIMES. REPEATED INCIDENTS WITH SEVERAL IDES NONE BUT RISK OF AES CAN YOU CONFIRM WHETHER SAMPLES ARE AVAILABLE FOR THE SURVEY? YES, 1 UNIT USED (DURING OR AFTER USE) IMPORTANT: IF USED, PLEASE CONFIRM WHETHER THE SAMPLES ARE CONTAMINATED WITH BLOOD OR CYTOTOXIC DRUGS. WITH BLOOD.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2437538 BD INSYTE AUTOGUARD WINGED PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4222720 00382903819232

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown