BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 10299756 · Received July 20, 2020

    Report

    Report Number
    9610847-2020-00212
    Event Type
    Malfunction
    Date Received
    July 20, 2020
    Date of Event
    June 28, 2020
    Report Date
    August 14, 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: OUR QUALITY ENGINEER REVIEWED THE PHOTOGRAPHS SUBMITTED FOR EVALUATION. UPON INSPECTION OF THE CUSTOMER PHOTOS LEAKAGE CAN BE OBSERVED COMING THROUGH ONE OF THE VENT HOLES ON THE Q-SYTE BODY. THIS LEAKAGE INDICATES DAMAGE TO THE SEPTUM INSIDE OF THE BODY. ALTHOUGH THE REPORTED ISSUE WAS CONFIRMED, IT COULD NOT BE DETERMINED IF THE DAMAGE RESULTED FROM THE MANUFACTURING OF THE DEVICE OR FROM THE USER ENVIRONMENT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE LEAKED AT THE HOLE OF THE SEPTUM DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "DURING THE USE OF Q-SYTE, LEAKAGE WAS FOUND AT THE HOLE OF THE SEPTUM."

    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 THE BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE LEAKED AT THE HOLE OF THE SEPTUM DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "DURING THE USE OF Q-SYTE, LEAKAGE WAS FOUND AT THE HOLE OF THE SEPTUM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764169 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