BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOG BC WING

    MDR report key: 21786768 · Received April 7, 2025

    Report

    Report Number
    1710034-2025-00523
    Event Type
    Malfunction
    Date Received
    April 7, 2025
    Date of Event
    March 11, 2025
    Report Date
    May 28, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE REPRESENTATIVE SAMPLES SUBMITTED FOR EVALUATION. BD RECEIVED 116 SEALED 20GA X 1.16IN. INSYTE AUTOGUARD BC WINGED UNITS FROM LOT #4242432. A SAMPLING OF 20 UNITS WERE RANDOMLY SELECTED FOR FUNCTIONAL TESTING. THE 20 UNITS WERE INSPECTED BY BREAKING TIP ADHESION, SLIGHTLY ADVANCING THE CATHETER, AND ACTIVATING THE BUTTON. THE BUTTON ACTIVATED SUCCESSFULLY AND ALL 20 UNITS RETRACTED INSTANTLY WITH NO RESISTANCE OR DEFECTS DISCOVERED. THE RETURNED UNITS 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 FAILURES STATED IN YOUR REPORT. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS. EXAMINATION OF THE ACTUAL PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.

    Additional Manufacturer Narrative · 0

    B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 WING NEEDLE DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿I WAS JUST NOTIFIED BY THE STAFF MEMBER INVOLVED THAT THE NEEDLE DID NOT RETRACT AFTER THE BUTTON TO RETRACT THE NEEDLE WAS PRESSED. THEY TRIED RETRACTING THE NEEDLE AGAIN AFTER THE IV WAS INSERTED WITH NO SUCCESS. THE NEEDLE WAS THEN PLACED STRAIGHT INTO THE SHARPS CONTAINER. THE EMPLOYEE SAVED THE PACKAGING FROM THE IV CATHETER THAT WAS USED WHICH IS WHERE I OBTAINED THE LOT NUMBER FROM. I AM NOT SURE IF THE NEEDLE WAS BENT IN ANY WAY EITHER. THERE WAS NO NEEDLE STICK INJURY IN THIS INCIDENT, JUST A FAULTY IV CATHTER. PLEASE LET ME KNOW IF YOU NEED ANY MORE INFORMATION.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1956908 BD INSYTE AUTOG BC WING PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4242432

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown