BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOG BC WING

    MDR report key: 20541450 · Received October 27, 2024

    Report

    Report Number
    1710034-2024-01214
    Event Type
    Malfunction
    Date Received
    October 27, 2024
    Date of Event
    October 3, 2024
    Report Date
    June 16, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903826339
    PMA / PMN Number
    K201075
    Removal / Correction Number
    MDS-25-5274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    501

    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. B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION OF FA#.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE SAMPLE SUBMITTED FOR EVALUATION. BD RECEIVED 50 SEALED 20G X 1.0 INCH INSYTE AUTOGUARD BC UNITS FROM LOT #4222721. A SAMPLING OF 20 UNITS WERE RANDOMLY SELECTED FOR TESTING. A FUNCTIONAL TEST REVEALED THAT THE RETRACTION TIME OF THREE NEEDLES EXCEEDED THE 1.5 SECOND SPECIFICATION. YOUR REPORTED ISSUE WAS CONFIRMED AS A SLOW RETRACTION. THIS WAS THE PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE REPORTED DEFECT RELATING TO EXCESSIVE GEL IN THE SPACE BETWEEN THE FLASH CHAMBER AND THE GRIP. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. HOWEVER, A TREND WAS IDENTIFIED FOR THE REPORTED FAILURE AND CORRECTIVE ACTIONS HAVE BEEN IMPLEMENTED TO INVESTIGATE THIS TYPE OF INCIDENT AND IDENTITY THE ROOT CAUSE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOG BC WING NEEDLE WAS SLOW TO RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I WANT TO MAKE YOU AWARE OF A PRODUCT COMPLAINT BEING MADE BY XXX THAT I RECEIVED 10/2/2024 FOR REF: 382633 LOT# 4222721. TO MY KNOWLEDGE THERE HAS BEEN NO PATIENT OR STAFF INJURY. I HAVE BEEN ABLE TO ASSESS THE DEVICES MYSELF AND THE SPRING DOES SEEM TO RETRACT VERY SLOW COMPARED TO ¿NORMAL¿ IN MY EXPERIENCE. WE HAVE SEVERAL SAMPLES YOU CAN HAVE FOR REVIEW. I WAS MADE AWARE THAT THERE WERE A LOT OF THESE (LOT #4222721) THAT WERE NOT RETRACTING LIKE THEY ARE SUPPOSED TO WHICH IS A SAFETY CONCERN, SO THEY HAVE ALL BEEN PULLED FROM THE ED. I WAS TOLD TO REACH OUT TO SEE IF THEY ARE SOMETHING THAT WE SHOULD BE SENDING BACK TO THE MANUFACTURER SO THEY CAN INVESTIGATE THE DEFECT OR IF I SHOULD JUST THROW THEM ALL OUT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2026614 INSYTE AUTOG BC WING PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4222721 00382903826339

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown