BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD WINGED

    MDR report key: 21837022 · Received April 14, 2025

    Report

    Report Number
    1710034-2025-00594
    Event Type
    Malfunction
    Date Received
    April 14, 2025
    Date of Event
    March 28, 2025
    Report Date
    April 24, 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 OF NEEDLE RETRACTION FAILURE WAS INITIATED DURING THE BUILD OF THIS LOT, AND QUALITY NOTIFICATION REVIEW (QN) COULD NOT BE PERFORMED FOR THE DEFECT OF NEEDLE RETRACTION SLOW. 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.

    Additional Manufacturer Narrative · 0

    B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 BDINSYTE AUTOGUARD WINGED NEEDLE WAS SLOW TO RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS ISSUE HAS ALREADY BEEN ADDRESSED AND NOT A NEW PROBLEM, ALTHOUGH IT IS STILL OCCURRING. IT IS NOT LOT SPECIFIC AS WE ARE STILL SEEING THE CONCERN WITH THE NEEDLES NOT RETRACTING (OR RETRACTING VERY SLOWLY). WHEN (B)(6) WAS HERE TO PICK UP THE AFFECTED CATHETERS, HE SAW THE LAG TIME OF THE RETRACTION OF THE NEEDLE. 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
    112838 BD INSYTE AUTOGUARD WINGED PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4212198

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown