BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD IAG BC PRO GLOBAL

    MDR report key: 21515977 · Received March 4, 2025

    Report

    Report Number
    1710034-2025-00353
    Event Type
    Malfunction
    Date Received
    March 4, 2025
    Date of Event
    February 17, 2025
    Report Date
    May 7, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903810123
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    E. FACILITY NAME CHARACTER LIMIT IS EXCEEDED: (B)(6). 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: OUR QUALITY ENGINEER INSPECTED THE SAMPLE AND PHOTOGRAPHS SUBMITTED FOR EVALUATION. YOUR REPORT OF A LEAK WAS CONFIRMED, AND THE CAUSE APPEARED TO BE MANUFACTURING RELATED. TWO PHOTOGRAPHS AND ONE 24G INSYTE AUTOGUARD IV CATHETER FROM LOT 4010706 WERE PROVIDED FOR INVESTIGATION. A HOLE IN THE CATHETER ADAPTER NEAR THE WEDGE APPEARED TO BE THE CAUSE OF THE REPORTED LEAK. THE HOLE APPEARED TO BE THE RESULT OF A MOLDING DEFECT. DURING ADAPTER LOADING IT IS POSSIBLE THAT INCORRECT FEEDER SETTINGS OR THE FEEDER JAMMING TO CAUSE ADAPTER DAMAGE. IT IS ALSO POSSIBLE THAT THIS DEFECT OCCURRED DURING MOLDING. MOLD MALFUNCTION, MOLD AVAILABILITY, OR PRODUCTION DISRUPTION MAY CAUSE MOLD/COMPONENT DAMAGE THAT MAY RESULT IN LEAKS. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD IAG BC PRO GLOBAL HUB IS CRACKED AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: ACCORDING TO THE CUSTOMER REPORT THE HUB OF THE CATHETER WAS CRACKED AND BLOOD LEAKED OUT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1146751 BD IAG BC PRO GLOBAL PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4010706 00382903810123

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown