BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD AIG BC PRO GLOBAL

    MDR report key: 22133474 · Received June 3, 2025

    Report

    Report Number
    1710034-2025-00939
    Event Type
    Malfunction
    Date Received
    June 3, 2025
    Date of Event
    May 14, 2025
    Report Date
    July 2, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903810123
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 381012 AND LOT NUMBER 4162504. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD IAG BC PRO GLOBAL POOR CONNECTION WITH LEAK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INTERRUPTION OF TREATMENT AT 3 REPETITIONS TO ADAPT THE TUBING TO THE CATHETER. 15 MAY. I CAN CONFIRM THAT THERE WAS NO CLINICAL IMPACT ON THE TWO PATIENTS, OTHER THAN THE LOSS OF THE PRODUCT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    888941 BD AIG BC PRO GLOBAL PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4162504 00382903810123

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown