BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD

    MDR report key: 21040113 · Received December 30, 2024

    Report

    Report Number
    1710034-2024-01555
    Event Type
    Malfunction
    Date Received
    December 30, 2024
    Date of Event
    December 11, 2024
    Report Date
    February 5, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903818235
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    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 381823 AND LOT NUMBER 4110699. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOGUARD LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER CALLED TO REPORT THAT AFTER INSERTION OF THE CATHETER 381823, THERE IS A LOT OF BLOOD RETURN WHEN THE NEEDLE IS REMOVED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2128429 BD INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4110699 00382903818235

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown