BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD

    MDR report key: 20444840 · Received October 14, 2024

    Report

    Report Number
    1710034-2024-01149
    Event Type
    Malfunction
    Date Received
    October 14, 2024
    Date of Event
    September 20, 2024
    Report Date
    November 18, 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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E. FACILITY NAME EXCEEDS CHARACTER LIMIT: (B)(6) MEDICAL CENTER. 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

    DEVICE BATCH NUMBER UPDATED IN D TAB. INVESTIGATION RESULTS: THE COMPLAINT OF A LEAK WAS CONFIRMED AND THE CAUSE WAS DETERMINED TO BE MANUFACTURING RELATED. FIVE PHOTOS AND ONE 24G INSYTE AUTOGUARD IV CATHETER FROM LOT 4110696 WERE PROVIDED FOR INVESTIGATION. THE SAMPLE EXHIBITED EVIDENCE OF USE. A BREACH IN THE CATHETER ADAPTER WAS IDENTIFIED DUE TO A MOLDING DEFECT. 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 AUTOGUARD HOLE IN HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: IT WAS REPORTED THAT WHEN THE NEEDLE WAS PUNCTURED, BLOOD LEAKED OUT OF THE HUB, AND UPON CHECKING, A PINHOLE OF ABOUT 0.5 MM WAS FOUND IN THE HUB. NO INFECTION, NO MEDICATION ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1715744 BD INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4110696 00382903810123

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown