BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOG BC

    MDR report key: 20659237 · Received November 11, 2024

    Report

    Report Number
    1710034-2024-01312
    Event Type
    Malfunction
    Date Received
    November 11, 2024
    Date of Event
    September 17, 2024
    Report Date
    February 18, 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
    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. E1. ADDRESS INFORMATION WAS NOT PROVIDED, THEREFORE, XX WAS USED AS A PLACE HOLDER.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: THANK YOU FOR SENDING IN YOUR SAMPLE; HOWEVER, THE SAMPLE APPEARS TO HAVE BEEN LOST. PLEASE UNDERSTAND THIS IS A RARE OCCURRENCE AND WE APOLOGIZE. SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED WERE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. SHOULD THE SAMPLE BE LOCATED, WE WILL REINVESTIGATE AND RESPOND BACK TO YOU WITH THE RESULTS. PRODUCTION RECORDS WERE REVIEWED, AND THESE BATCHES MEET OUR MANUFACTURING SPECIFICATION REQUIREMENTS. 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 DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LOT#4162541 BUTTON STUCK.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1135681 BD INSYTE AUTOG BC PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4190491 00382903825448

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown