BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD WINGED

    MDR report key: 21835323 · Received April 14, 2025

    Report

    Report Number
    1710034-2025-00583
    Event Type
    Malfunction
    Date Received
    April 14, 2025
    Date of Event
    March 25, 2025
    Report Date
    April 23, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 381533 AND LOT NUMBER 4212198. A QUALITY NOTIFICATION RELATED TO THE REPORTED DEFECT WAS INITIATED DURING THE BUILD OF THIS LOT, HOWEVER WITHOUT A SAMPLE WE CANNOT CONFIRM THAT THIS FAILURE WAS RELATED TO THAT NOTIFICATION. BASED ON THE AVAILABLE INFORMATION, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED.

    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: WE ARE HAVING ISSUES WITH THE NEEDLE NOT RETRACTING ONCE THE SAFETY MECHANISM HAS BEEN ENGAGED. THESE ISSUES ARE STILL OCCURRING, AND THIS POSES A SIGNIFICANT SAFETY ISSUE FOR OUR PATIENTS AND MY ASSOCIATES. NO INJURIES HAVE OCCURRED, BUT IT COULD POTENTIALLY CAUSE A NEEDLE STICK INJURY IF THE ASSOCIATE IS NOT AWARE THAT THE NEEDLE HAS NOT YET RETRACTED WHEN THEY GO TO PULL IT FROM THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2425302 BD INSYTE AUTOGUARD WINGED PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4212198

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown