BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AG BC GLOBAL

    MDR report key: 20678471 · Received November 13, 2024

    Report

    Report Number
    1710034-2024-01331
    Event Type
    Malfunction
    Date Received
    November 13, 2024
    Date of Event
    October 28, 2024
    Report Date
    January 28, 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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE SAMPLES AND PHOTOGRAPHS SUBMITTED FOR EVALUATION. BD RECEIVED TWO UNSEALED 24GA X 0.75IN. INSYTE AUTOGUARD BC UNITS FROM LOT NUMBER 4010706. ADDITIONALLY, 5 PHOTOS WERE PROVIDED. ONLY THE CATHETERS WERE PROVIDED. A FUNCTIONAL TEST REVEALED A LEAK FROM EACH YELLOW CATHETER ADAPTER. A BREACH WAS IDENTIFIED IN EACH ADAPTER. YOUR REPORT OF A HOLE IN THE HUB WAS CONFIRMED. THIS WAS PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE REPORTED DEFECT RELATING TO THE MOLDING PROCESS. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.

    Additional Manufacturer Narrative · 0

    A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AG BC GLOBAL HAS A HOLE IN THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: IT WAS REPORTED THAT THERE WAS A HOLE IN THE HUB PART AFTER THE PUNCTURE, SO BLOOD LEAKED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2009193 BD INSYTE AG BC GLOBAL PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4010706 00382903810123

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown