BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD

    MDR report key: 20526582 · Received October 24, 2024

    Report

    Report Number
    1710034-2024-01194
    Event Type
    Malfunction
    Date Received
    October 24, 2024
    Date of Event
    September 24, 2024
    Report Date
    December 9, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903814121
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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 SAMPLE SUBMITTED FOR EVALUATION. BD RECEIVED ONE 24GX0.75IN INSYTE AUTOGUARD DEVICE FROM LOT NUMBER 4072326. A GROSS VISUAL INSPECTION SHOWS THAT ONLY THE CATHETER ASSEMBLY WAS RETURNED, AND IT APPEAR TO HAVE A DAMAGE NEAR THE TIP OF THE CATHETER. FURTHER MICROSCOPIC INSPECTION SHOWED THAT THE CATHETER HAD A V-SHAPE DAMAGE NEAR ITS TIP. THE OBSERVED DAMAGE IS IDENTICAL TO THAT CREATED WHEN THE NEEDLE PIERCES THE CATHETER WALL NEAR THE TIP GIVING A SPEAR THROUGH, THUS CONFIRMING YOUR REPORTED ISSUE OF NEEDLE THROUGH CATHETER. ALTHOUGH YOUR REPORTED ISSUE WAS CONFIRMED, IT COULD NOT BE DETERMINED IF THE DAMAGE RESULTED FROM THE MANUFACTURING OF THE DEVICE OR FROM THE USER ENVIRONMENT. DURING MANUFACTURING THIS MAY OCCUR DUE TO ALIGNMENT OF THE SET TOGETHER STATION, BENT TUBING, OR AIR BLOW INCONSISTENCY. THERE IS A 100 PERCENT AUTOMATED VISION SYSTEM INSPECTION, AND A SAMPLING PLAN IMPLEMENTED FOR TIP SPEAR WHICH MITIGATES THE OCCURRENCE OF THIS DEFECT. HOWEVER, AS THE RETURNED UNIT HAS BEEN REMOVED FROM THE PACKAGE AND HANDLED IT IS POSSIBLE THAT THE DEFECTS ORIGINATED IN THE USER ENVIRONMENT. 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 AUTOGUARD CATHETER SHREDDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONE OF OUR INTERMOUNTAIN FACILITIES IS REPORTING AN ISSUE/CONCERN WITH AN ITEM THAT IT IS PURCHASED FROM YOUR COMPANY. ISSUE: 24G PIV THE CATHETER SHREDDED UPON INSERTION AND LED TO THE PATIENT BEING POKED MULTIPLE TIMES. EVENT DATE: (B)(6) 2024. WAS THERE INJURY? LED TO THE PATIENT BEING POKED MULTIPLE TIMES.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1856745 BD INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4072326 00382903814121

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown