BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOG BC

    MDR report key: 21855683 · Received April 17, 2025

    Report

    Report Number
    1710034-2025-00610
    Event Type
    Malfunction
    Date Received
    April 17, 2025
    Date of Event
    March 17, 2025
    Report Date
    June 16, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825448
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    003

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE REPRESENTATIVE SAMPLES SUBMITTED FOR EVALUATION. BD RECEIVED 339 SEALED 18GA X 1.16IN. INSYTE AUTOGUARD BC UNITS FROM LOT NUMBER 5010456. A SAMPLING OF 20 UNITS WERE RANDOMLY SELECTED FOR TESTING. THE 20 UNITS WERE INSPECTED BY BREAKING TIP ADHESION, SLIGHTLY ADVANCING THE CATHETER, AND ACTIVATING THE BUTTON. A STOPWATCH WAS USED TO MEASURE THE TIME BETWEEN BUTTON ACTIVATION AND FULL NEEDLE RETRACTION. OUT OF THE 20 UNITS TESTED, 9 OF THEM DISPLAYED A PARTIAL RETRACTION. THERE DID NOT APPEAR TO BE A DELAY OF RETRACTION AFTER BUTTON ACTIVATION, BUT THE NOTCH APPEARED TO GET STUCK TO THE SEPTUM, PREVENTING FULL NEEDLE RETRACTION. THE UNITS WERE DISSECTED TO INSPECT THE SEPTUM, BUT NO DAMAGES OR IMPROPER CUTS WERE DISCOVERED. THE PARTIAL RETRACTION WAS DETERMINED TO BE A MANUFACTURING RELATED ISSUE DUE TO INCORRECT EQUIPMENT SETTINGS WHICH MAY CAUSE AN INSUFFICIENT AMOUNT OF LUBE RESULTING IN A HIGH INITIAL ADHESION. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOG BC NEEDLE DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE IDENTIFIED A PRODUCT ISSUE WITH THE ATTACHED INSYTE, SPECIFICALLY WITH THIS LOT. SEVERAL NURSES HAVE ENCOUNTERED THE NEEDLE NOT REJECTING BACK CAUSING CLOSE CALLS WITH NEEDLESTICKS AND PATIENT SAFETY ISSUES. INJURIES OR ADVERSE EVENT: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31609 BD INSYTE AUTOG BC PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5010456 00382903825448

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown