BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOG BC

    MDR report key: 21845730 · Received April 15, 2025

    Report

    Report Number
    1710034-2025-00596
    Event Type
    Malfunction
    Date Received
    April 15, 2025
    Date of Event
    March 26, 2025
    Report Date
    June 25, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: THE COMPLAINT THAT THE NEEDLE GETS STUCK WITH SUBSEQUENT BLEEDING WAS CONFIRMED FOR LOT # 5010456. REPRESENTATIVE SAMPLES FROM LOTS 4347515 AND 5010456 WERE RECEIVED IN SEALED UNIT PACKAGES. A FUNCTIONAL TEST OF THE SAFETY MECHANISM REVEALED THAT THE NEEDLES FROM LOT 4347515 FULLY RETRACTED AND NO LEAKS WERE NOTED AT THE SEPTUM. FOR LOT 5010456, THE FLASH NOTCH ON 3 OF THE 20 TESTED UNITS BECAME CAUGHT ON THE BLOOD CONTROL VALVE UPON ACTIVATING THE SAFETY MECHANISM AND THE NEEDLE KEPT THE VALVE IN AN OPEN POSITION. THE DIMENSIONS OF THE NEEDLE WERE WITHIN SPECIFICATION. AS THE SAMPLES FROM SEALED UNIT PACKAGES FAILED TO FULLY RETRACT, THE COMPLAINT WAS CONFIRMED, AND THE CAUSE APPEARED TO BE MANUFACTURING RELATED. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY.

    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 AUTOG BC NEEDLE DEFECT LEADING TO SLOW RETRACTION AND LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I HAVE HAD SEVERAL 18G IV'S THAT WHEN YOU PUSH THE BUTTON TO RETRACT THE NEEDLE IT GETS STUCK PART WAY. IT THEN BREAKS THE SEAL AND CAUSES HE CATHETER TO START TO BLEED EVERYWHERE. YOU MUST OCCLUDE ABOVE IT AND THEN PULL THE NEEDLE OUT AND THEN IT WILL RETRACT THE REST OF THE WAY. IT CAUSES BLOOD TO GET EVERYWHERE, INCREASES THE RISK FOR A NEEDLE STICK IN MY OPINION, AND INCREASES THE CHANCES OF THE IV ACCIDENTLY BEING PULLED. WHEN WE PRESS THE BOTTOM TO RETRACT THE NEEDLE, THE NEEDLE GETS STUCK HALFWAY CAUSES THE OCCLUDING SEAL TO BREAK AND BLOOD COMES RUSHING OUT. MAKING IT SO WE MISS THE IV BECAUSE WHEN WE TRY TO PULL THE NEEDLE BACK IT TAKES THE CATHETER WITH IT. I HAVE ALSO HAD ISSUES WHERE AS SOON AS I POKE THE PATIENT, THE NEEDLE WILL RETRACT ITSELF RIGHT AWAY AND THE TIP OF THE CATHETER IS IN THE PATIENT. BACKGROUND: EVENT DATE: (B)(6) 2025. WAS THERE INJURY? ERRORS ARE OCCURRING WITHOUT HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2348896 BD INSYTE AUTOG BC PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5010456

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown