BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD Q-SYTE CLOSED LUER ACCESS DEVICE

    MDR report key: 21820885 · Received April 10, 2025

    Report

    Report Number
    1710034-2025-00562
    Event Type
    Malfunction
    Date Received
    April 10, 2025
    Date of Event
    March 15, 2025
    Report Date
    April 22, 2025
    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 385100 AND LOT NUMBER 3213081. 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

    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 BD Q-SYTE CLOSED LUER ACCESS DEVICE LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: ON (B)(6) 2025, I WAS TREATED IN OUR HOSPITAL FOR CEREBRAL INFARCTION. AT 9:00 A.M., AFTER THE NURSE FINISHED DISINFECTING, HE CONNECTED THE INFUSION CATHETER TO THE SEPTUM NEEDLELESS INJECTION CAP. AFTER TURNING ON THE INFUSION DEVICE, FLUID LEAKED FROM THE CAP, SOAKING THE PATIENT'S CLOTHES. HE IMMEDIATELY TURNED IT OFF AND FOUND THAT THE CAP WAS LEAKING IN A SPRAY-LIKE MANNER. HE REPLACED IT WITH A NEW ONE AND OBSERVED THAT NO MORE FLUID LEAKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1015753 BD Q-SYTE CLOSED LUER ACCESS DEVICE SET, ADMINISTRATION, INTRAVASCULAR FPA BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3213081

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown