BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE

    MDR report key: 9459679 · Received December 12, 2019

    Report

    Report Number
    9610847-2019-00738
    Event Type
    Malfunction
    Date Received
    December 12, 2019
    Date of Event
    November 26, 2019
    Report Date
    January 20, 2020
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    30382903851004
    PMA / PMN Number
    K013621
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION: DHR FOR LOT 9190023, 9190039, 9190496 HAS BEEN REVIEWED. NO RELATED QUALITY ISSUES OR PROCESS DEVIATIONS WERE FOUND. THE DEFECT OF OTHER COULD NOT BE REFUTED NOR CONFIRMED IN THE ABSENCE OF A SAMPLE. THE ROOT CAUSE CANNOT BE DETERMINED FOR AN UNCONFIRMED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE IT IS DISCOVERED THAT THE DEVICE IS DAMAGED WITH A BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FROM THE HOSPITAL WARD THEY HAVE RECEIVED INFO, THAT THERE IS A BROKEN ONES. MANY OF THOSE NOT WORKING: SILICON VALVES GET OFF THE EDGES. (WE KNOW THEY ARE USING SWABCAP).

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE IT IS DISCOVERED THAT THE DEVICE IS DAMAGED WITH A BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FROM THE HOSPITAL WARD THEY HAVE RECEIVED INFO, THAT THERE IS A BROKEN ONES. MANY OF THOSE NOT WORKING: SILICON VALVES GET OFF THE EDGES. (WE KNOW THEY ARE USING SWABCAP).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1258077 BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE INTRAVASCULAR ADMINISTRATION SET FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 385100 9204391 30382903851004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other