BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD WINGED

    MDR report key: 21565151 · Received March 10, 2025

    Report

    Report Number
    1710034-2025-00382
    Event Type
    Malfunction
    Date Received
    March 10, 2025
    Date of Event
    February 21, 2025
    Report Date
    March 21, 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
    CA
    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: 381923 AND LOT NUMBER: 4222720. 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.

    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: DATE OF INCIDENT (YYYY-MM-DD): 2025-02-21. LEVEL OF HARM: NO APPARENT HARM - REACHED THE PATIENT/PERSON. INCIDENT DETAILS: WHEN STARTING AN IV WITH THE 22GA ANGIOCATHS, THE NEEDLE DOES NOT RETRACT WHEN THE BUTTON IS PRESSED AND/OR THERE IS A DELAY IN THE RETRACTION OF THE NEEDLE. FREQUENCY OF PROBLEM: MULTIPLE TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1253749 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