BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOG BC PNK 20GA X 1.16IN

    MDR report key: 22199677 · Received June 12, 2025

    Report

    Report Number
    1710034-2025-01005
    Event Type
    Malfunction
    Date Received
    June 12, 2025
    Date of Event
    May 23, 2025
    Report Date
    August 5, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825349
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT THAT THE NEEDLE DOES NOT SAFETY COULD NOT BE CONFIRMED FROM THE REPRESENTATIVE 20GA INSYTE AUTOGUARD UNITS THAT WERE RECEIVED IN SEALED UNIT PACKAGING FROM LOT #5010448. A FUNCTIONAL TEST REVEALED THAT THE NEEDLE FULLY RETRACTED, AND THE RETRACTION TIME WAS WITHIN SPECIFICATION. NO DAMAGE OR DEFECTS WERE IDENTIFIED ON THE RETURNED SAMPLES. FAILURE TO LOOSEN THE CATHETER FROM THE NEEDLE AS INSTRUCTED IN THE IFU CAN AFFECT NEEDLE RETRACTION. PRIOR TO ACCESSING THE VESSEL, THE INSTRUCTIONS FOR USE STATE, "HOLD THE CATHETER HUB AND ROTATE THE BARREL 360-DEGREES TO LOOSEN THE CATHETER TUBING FROM THE NEEDLE." THE AFFECTED UNIT WAS NOT PROVIDED FOR INVESTIGATION, AND THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. ALTHOUGH THE REPRESENTATIVE SAMPLES AND MANUFACTURING RECORDS DO NOT SUPPORT THE COMPLAINANT¿S DESCRIPTION OF THE REPORTED EVENT, THE COMPLAINT HAS BEEN DOCUMENTED AND WILL CONTINUE TO BE MONITORED AS PART OF ONGOING EFFORTS TO IDENTIFY POTENTIAL MANUFACTURING RELATED ISSUES. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT THE NEEDLE DOES NOT SAFETY AFTER INSERTION. VERBATIM: MATERIAL: 382534, BATCH#: 5010448. THE NEEDLE DOES NOT SAFETY AFTER INSERTION. THIS ISSUE HAS BEEN NOTICED AMONG SEVERAL DIFFERENT LOT SIZES.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635446 INSYTE AUTOG BC PNK 20GA X 1.16IN CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5010448 00382903825349

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown