BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD Q-SYTE 15CM SMALL BORE BI-EXT SET

    MDR report key: 21203262 · Received January 21, 2025

    Report

    Report Number
    9610847-2025-00001
    Event Type
    Malfunction
    Date Received
    January 21, 2025
    Date of Event
    December 28, 2024
    Report Date
    February 5, 2025
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    00382903851577
    PMA / PMN Number
    K142527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 385157 AND LOT NUMBER 4061404. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. THERE ARE QUALITY CONTROLS CURRENTLY IN PLACE TO DETECT THIS TYPE OF DEFECT DURING THE PRODUCTION PROCESS. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD Q-SYTE 15CM SMALL BORE BI-EXT SET LEAKED DRUG LEAKAGE FROM Q-SYTE BI EXTENSION IN RADIOLOGY DEPARTMENT. THEY HAVE GIVEN CT CONTRAST AT 5.5ML PER SECOND WITH OVERALL VOLUME OF 80ML THROUGH PRESSURE INJECTOR. THEY HAVE NOTICED DRUG LEAKAGE FROM Q-SYTE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682211 BD Q-SYTE 15CM SMALL BORE BI-EXT SET INTRAVASCULAR ADMINISTRATION SET FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 4061404 00382903851577

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown