BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 10336352 · Received July 28, 2020

    Report

    Report Number
    9610847-2020-00220
    Event Type
    Malfunction
    Date Received
    July 28, 2020
    Date of Event
    July 3, 2020
    Report Date
    August 24, 2020
    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: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED WERE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. THE DHR FOR SUBLOT'S 9092712, 9092711 AND 9088726 WERE REVIEWED. ONE RELATED QN WAS FOUND, QN# (B)(6), FOR 9092711. NO OTHER RELATED QUALITY ISSUES OR PROCESS DEVIATIONS WERE FOUND. THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT LIQUID LEAKED BETWEEN THE BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE AND INFUSION SET CONNECTION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "DURING THE INFUSION, LIQUID LEAKAGE AT THE CONNECTION BETWEEN THE INFUSION SET AND Q-SYTE CONNECTOR".

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LIQUID LEAKED BETWEEN THE BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE AND INFUSION SET CONNECTION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "DURING THE INFUSION, LIQUID LEAKAGE AT THE CONNECTION BETWEEN THE INFUSION SET AND Q-SYTE CONNECTOR".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799915 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 9122580 30382903851004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other