BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Q-SYTE 15CM MACRO BORE BI-EXT SET

    MDR report key: 9660970 · Received February 3, 2020

    Report

    Report Number
    9610847-2020-00032
    Event Type
    Malfunction
    Date Received
    February 3, 2020
    Date of Event
    January 13, 2020
    Report Date
    January 15, 2020
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K142527
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    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 Q-SYTE 15CM MACRO BORE BI-EXT SET TUBING KINKED DURING USE WHEN ATTEMPTING TO PERFORM THE "J LOOP". THIS OCCURRED ON 10 SEPARATE OCCASIONS, BUT THE DATES AND/OR PATIENT INFORMATION ARE UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "KINKING OF THE LUMEN WHEN THEY TRY TO DO J LOOP FOR SECURING THE LUMEN. SO THE FLOW IS GETTING AFFECTED BECAUSE OF THAT KINK".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126302 Q-SYTE 15CM MACRO BORE BI-EXT SET INTRAVASCULAR ADMINISTRATION SET FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 9014671

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other