BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOG BC

    MDR report key: 19996686 · Received August 15, 2024

    Report

    Report Number
    1710034-2024-00886
    Event Type
    Malfunction
    Date Received
    August 15, 2024
    Date of Event
    July 23, 2024
    Report Date
    October 4, 2024
    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
    WI, 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 UNSEALED AND RETRACTED 18GA X 1.16IN. INSYTE AUTOGUARD BC UNIT FROM LOT NUMBER 4152064. A VISUAL INSPECTION WAS PERFORMED FOR ANY DAMAGE TO THE BUTTON, SPRING, NEEDLE, NEEDLE HUB, OR GRIP. NO DAMAGES WERE DISCOVERED, AND NO SIGN OF ADHESIVE WAS DISCOVERED. THE CANNULA WAS PLACED BACK INTO ITS INITIAL POSITION AND ATTEMPTED TO RETRACT WITH THE CATHETER SLIGHTLY ADVANCED OFF THE CANNULA. THE CANNULA RETRACTED SUCCESSFULLY WITH NO ISSUES. IT IS POSSIBLE THAT TIP ADHESION WAS NOT BROKEN OR THE CATHETER WAS NOT ADVANCED OFF THE CANNULA BEFORE RETRACTING. THIS MAY CAUSE ISSUES RETRACTING DURING USE. WITHOUT BEING ABLE TO REPLICATE THE REPORTED DEFECT, THE REPORTED DEFECT COULD NOT BE CONFIRMED. THE RETURNED UNIT PROVIDED FOR EVALUATION MET AND PERFORMED PER THE REQUIRED MANUFACTURING SPECIFICATIONS. THERE WAS NO PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE FAILURE STATED IN YOUR REPORT. 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: DATE: JULY 23RD 2024. DESCRIPTION OF EVENTS: THE EVENT WAS REPORTED BY A NURSE IN THE WOMEN'S HEALTH DEPARTMENT. THE ANGIOCATH IS BEING USED TO START AN IV THE NURSE WENT TO RETRACT THE NEEDLE BY PRESSING THE BUTTON ON THE DEVICE THE NEEDLE GOT STUCK AND THE NEEDLE WOULD NOT RETRACT INTO THE CATHETER.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    992402 BD INSYTE AUTOG BC PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4152064 00382903825448

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown