BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOG BC

    MDR report key: 20313433 · Received September 26, 2024

    Report

    Report Number
    1710034-2024-01045
    Event Type
    Malfunction
    Date Received
    September 26, 2024
    Date of Event
    September 2, 2024
    Report Date
    November 13, 2024
    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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 382544 AND LOT NUMBER 4152064. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. BASED ON THE AVAILABLE INFORMATION, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    CORRECTION: THE AS REPORTED CODE HAS BEEN CORRECTED TO "NEEDLE RETRACTION FAILURE" SINCE IT IS THE CORRECT FAILURE MODE TYPE.

    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. E1. ADDRESS INFORMATION WAS NOT PROVIDED, THEREFORE, XX WAS USED AS A PLACE HOLDER.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    THE AS REPORTED DEFECT CODE IS BEING CORRECTED TO "NEEDLE RETRACTION FAILURE".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOG BC SAFETY FEATURE DELAY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CLINICIAN WAS UNABLE TO USE THE ACTIVE SAFETY BUTTON WHILE IV CATHETER WAS STILL IN THE PATIENT'S VEIN. AFTER PULLING THE NEEDLE OUT OF THE VEIN, THEY WERE ABLE TO SAFETY THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1830457 INSYTE AUTOG BC PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4152064 00382903825448

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown