BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD Q-SYTE EXT SET

    MDR report key: 19877821 · Received July 31, 2024

    Report

    Report Number
    1710034-2024-00805
    Event Type
    Malfunction
    Date Received
    July 31, 2024
    Date of Event
    June 30, 2024
    Report Date
    August 9, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FPA
    PMA / PMN Number
    K013621
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 385102 AND LOT NUMBER 1210970. 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.

    Additional Manufacturer Narrative · 0

    H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD Q-SYTE EXT SET LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: ON (B)(6) 2024, THE CHILD NEEDED REHYDRATION TREATMENT DUE TO HIS CONDITION. AT 13:00, INTRAVENOUS INFUSION WAS GIVEN AND A NEEDLELESS SEALED INFUSION CONNECTOR WAS CONNECTED. WHEN INSPECTING THE PATIENT AT 13:30, THE BED UNIT WAS FOUND TO BE DAMP. AFTER INVESTIGATION, IT WAS FOUND THAT THE NEEDLELESS SEALED INFUSION CONNECTOR WAS IF THERE IS WATER LEAKAGE, REPLACE THE CONNECTOR WITH A NEW ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739890 BD Q-SYTE EXT SET SET, ADMINISTRATION, INTRAVASCULAR FPA BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 1210970

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown