BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD

    MDR report key: 19121916 · Received April 16, 2024

    Report

    Report Number
    1710034-2024-00334
    Event Type
    Malfunction
    Date Received
    April 16, 2024
    Date of Event
    March 21, 2024
    Report Date
    July 18, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903814237
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE SAMPLE SUBMITTED FOR EVALUATION. BD RECEIVED 2 UNITS OF A 22GX1.00IN INSYTE AUTOGUARD DEVICE FROM LOT 3222380 FOR THE INVESTIGATION OF THIS COMPLAINT. A GROSS VISUAL INSPECTION SHOWS THAT ONE UNIT HAS BEEN USED AND THE OTHER UNIT IS STILL SEALED IN ITS PACKAGING. THE SEALED UNIT WAS REMOVED OUT OF ITS PACKAGING AND AFTER PERFORMING TIP ADHESION BREAK, THE SAFETY BUTTON WAS PUSHED, AND THE NEEDLE SMOOTHLY RETRACTED IN THE BARREL. ON THE USED UNIT, THE SAFETY BUTTON SHOWED NO EVIDENCE OF BEING ACTIVATED AND THE NEEDLE WAS NOT RETRACTED IN THE BARREL. UPON PRESSING THE SAFETY BUTTON ON THE USED UNIT, THE NEEDLE DID NOT RETRACT. THE REPORTED NONCONFORMANCE WAS CONFIRMED. MICROSCOPIC INSPECTION OF THE DEVICE WAS PERFORMED, AND THE DEVICE WAS FOUND TO HAVE ADHESIVE BINDING THE SAFETY BUTTON, PROHIBITING PROPER ACTIVATION. THIS WAS THE PHYSICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE REPORTED DEFECT RELATING TO A MISALIGNMENT OF THE AUTOMATED ADHESIVE DISPENSER. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.

    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

    IT WAS REPORTED THAT BD INSYTE AUTOGUARD NEEDLE DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INJURIES OR ADVERSE EVENT: NO. THE SAFETY MECHANISM FAILS AND THE NEEDLE WILL NOT RETRACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1892568 BD INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3222380 00382903814237

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown