BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOG BC

    MDR report key: 20025457 · Received August 22, 2024

    Report

    Report Number
    1710034-2024-00901
    Event Type
    Malfunction
    Date Received
    August 22, 2024
    Date of Event
    July 29, 2024
    Report Date
    August 23, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825127
    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

    BATCH NUMBER ADDED IN D TAB. INVESTIGATION RESULTS: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 382512 AND LOT NUMBER 4123606. 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. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED.

    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. FACILITY NAME NOT REPORTED. FACILITY STATE NOT REPORTED, IL USED AS A PLACE HOLDER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOG BC CATHETER BENDS AFTER INSERTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONCE PLACED THE CATHETER IS "BENDING" OR FOLDING OVER ON ITSELF (WHEN IT IS IN THE VEIN) AND THEN WE ARE UNABLE TO USE THE IV AT ALL AND NEED TO PLACE A WHOLE NEW IV.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1118351 BD INSYTE AUTOG BC PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4123606 00382903825127

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown