BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOG BC

    MDR report key: 20849145 · Received December 4, 2024

    Report

    Report Number
    1710034-2024-01430
    Event Type
    Malfunction
    Date Received
    December 4, 2024
    Date of Event
    November 13, 2024
    Report Date
    January 3, 2025
    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
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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: THE COMPLAINT THAT THE NEEDLE WOULD NOT RETRACT COULD NOT BE CONFIRMED FROM THE RETURNED 18GA INSYTE AUTOGUARD BC UNIT FROM LOT: 4222728. THE NEEDLE WAS RECEIVED FULLY RETRACTED AND A FUNCTIONAL TEST SHOWED THAT THE NEEDLE WOULD RETRACT WITHOUT ANY PROBLEMS. ALTHOUGH THE RETURNED SAMPLE 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 THAT BD INSYTE AUTOG BC NEEDLE DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I USED AN 18 G CATHETER NEEDLE FOR THIS EXAM THAT WOULD NOT RETRACT. IF YOU HAVE RECEIVED THIS MESSAGE IN ERROR. 15 NOV. KINDLY PROVIDE THE DATE OF EVENT. 11/13/2024. 232PM. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1871909 BD INSYTE AUTOG BC PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4222728 00382903825448

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown