BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AG BC GLOBAL

    MDR report key: 20036060 · Received August 22, 2024

    Report

    Report Number
    1710034-2024-00915
    Event Type
    Malfunction
    Date Received
    August 22, 2024
    Date of Event
    July 25, 2024
    Report Date
    October 3, 2024
    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

    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: THE COMPLAINT OF A LEAK WAS CONFIRMED, AND THE CAUSE APPEARED TO BE MANUFACTURING RELATED. FOUR PHOTOGRAPHS AND ONE 24GA INSYTE AUTOGUARD BC UNIT FROM LOT: 4010706 WERE PROVIDED FOR INVESTIGATION. THE CHARACTERISTICS OF THE LEAK SITE INDICATE THAT THE YELLOW CATHETER ADAPTER WAS NOT PROPERLY FORMED DURING MOLDING. A HOLE WAS OBSERVED IN THE MATERIAL, WHICH WOULD ALLOW FLUID TO LEAK. THE APPROPRIATE MANUFACTURING PERSONNEL WERE NOTIFIED OF THIS COMPLAINT. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AG BC GLOBAL HUB IS CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: ACCORDING TO THE CUSTOMER REPORT CHEMICAL LEAKED OUT DUE TO DUE CRACKS IN THE HUB DURING USE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23923 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