BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD Q-SYTE EXT SET, LUER-LOK 6 IN MICRO BORE

    MDR report key: 19666476 · Received July 3, 2024

    Report

    Report Number
    9610847-2024-00182
    Event Type
    Malfunction
    Date Received
    July 3, 2024
    Date of Event
    January 26, 2024
    Report Date
    July 12, 2024
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    00382903851027
    PMA / PMN Number
    K013621
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 385102 AND LOT NUMBER 3192828. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT 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.

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD Q-SYTE EXT SET, LUER-LOK 6 IN MICRO BORE LEAKED THE PATIENT UNDERWENT CEREBRAL ANEURYSM CLAMPING + INTRACRANIAL HEMATOMA REMOVAL UNDER GENERAL ANESTHESIA IN THE OPERATING ROOM DUE TO CEREBRAL ANEURYSM RUPTURE WITH SUBARACHNOID HEMORRHAGE, AND WAS ADMITTED TO THE ICU FROM THE OPERATING ROOM WITH RIGHT JUGULAR VEIN CANNULA AT 20:20 ON JANUARY 22, AND WAS REPLACED WITH A SEPTAL NEEDLELESS CLOSED TRANSFUSION CONNECTOR AT 08:00 ON JANUARY 23. AT 8:00 ON JANUARY 23, THE SEPTAL NEEDLELESS CLOSED INFUSION CONNECTOR WAS REPLACED, AND AT 14:00 ON JANUARY 26, WHEN THE CVP WAS MEASURED, THE SEPTAL NEEDLELESS CLOSED INFUSION CONNECTOR WAS FOUND TO BE LEAKING BADLY, AND WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757206 BD Q-SYTE EXT SET, LUER-LOK 6 IN MICRO BORE INTRAVASCULAR ADMINISTRATION SET FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 3192828 00382903851027

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown