BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD Q-SYTE LUER ACCESS

    MDR report key: 13079383 · Received December 23, 2021

    Report

    Report Number
    9610847-2021-00610
    Event Type
    Malfunction
    Date Received
    December 23, 2021
    Date of Event
    November 15, 2021
    Report Date
    January 24, 2022
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY : BD WAS UNABLE TO PERFORM A THOROUGH INVESTIGATION AS NO SAMPLE, LOT, OR BATCH NUMBER WERE PROVIDED. A DEVICE HISTORY REVIEW COULD NOT BE COMPLETED AS NO BATCH NUMBER WAS PROVIDED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED UNSPECIFIED BD Q-SYTE LUER ACCESS WAS DAMAGED, CAUSING LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): "IT WAS FOUND THAT THE MIDDLE OF Q-SYTE WAS BROKEN, AND THE LIQUID MEDICINE SPILLED ON THE PATIENT'S HAND, CAUSING DISCOMFORT."

    Description of Event or Problem · 0

    IT WAS REPORTED UNSPECIFIED BD Q-SYTE LUER ACCESS WAS DAMAGED, CAUSING LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "...IT WAS FOUND THAT THE MIDDLE OF Q-SYTE WAS BROKEN, AND THE LIQUID MEDICINE SPILLED ON THE PATIENT'S HAND, CAUSING DISCOMFORT.".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1977162 UNSPECIFIED BD Q-SYTE LUER ACCESS INTRAVASCULAR ADMINISTRATION SET FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown