BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 11573065 · Received March 25, 2021

    Report

    Report Number
    9610847-2021-00117
    Event Type
    Malfunction
    Date Received
    March 25, 2021
    Date of Event
    March 2, 2021
    Report Date
    June 2, 2021
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    30382903851004
    PMA / PMN Number
    K013621
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD RECEIVED A Q-SYTE CLOSED LUER ACCESS DEVICE FROM LOT 0146019 FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER VISUALLY INSPECTED THE RETURNED UNIT AND OBSERVED NO VISIBLE DAMAGE TO THE TOP DISK OR Q-SYTE BODY. THE SEPTUM WAS THEN INSPECTED AND A COLUMN TEAR WAS FOUND INDICATING A POSSIBLE LEAKAGE. A VIDEO OF THE UNIT LEAKING WAS ALSO PROVIDED. THEREFORE, BASED OFF THE OBSERVED COLUMN TEAR AND VIDEO PROVIDED THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT. UNFORTUNATELY, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE HAD A HOLE IN THE SCREW BUTTON THAT CAUSED LIQUID TO LEAK OUT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "DURING THE USE OF THE PRODUCT, THE USER FOUND A HOLE IN THE SCREW BUTTON AND LIQUID LEAKAGE OCCURRED."

    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 THE BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE HAD A HOLE IN THE SCREW BUTTON THAT CAUSED LIQUID TO LEAK OUT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "DURING THE USE OF THE PRODUCT, THE USER FOUND A HOLE IN THE SCREW BUTTON AND LIQUID LEAKAGE OCCURRED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469479 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 0146019 30382903851004

    Patients

    Seq Age Sex Outcome Treatment
    1