BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD Q-SYTE CLOSED LUER ACCESS DEVICE

    MDR report key: 20529918 · Received October 24, 2024

    Report

    Report Number
    1710034-2024-01196
    Event Type
    Malfunction
    Date Received
    October 24, 2024
    Date of Event
    September 20, 2024
    Report Date
    October 3, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FPA
    UDI-DI
    00382903851003
    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

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER: 385100 AND LOT NUMBER: 3152068. A COMPLAINT HISTORY CHECK WAS PERFORMED, AND THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH LEAKAGE WITH LOT#: 3152068 REGARDING ITEM: 385100. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD Q-SYTE CLOSED LUER ACCESS DEVICE LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: WHEN THE NURSE SEALS THE PATIENT, SHE FINDS THAT THE INFUSION CONNECTOR IS LEAKING. IN ADDITION, THE LIQUID LEAKAGE OCCURRED AFTER THE PRODUCT HAD BEEN USED FOR 4 DAYS. THE CUSTOMER DISCARDED THE PRODUCT AFTER NOTICING THE LIQUID LEAKAGE. THE PRODUCT INFORMATION PROVIDED IS FOR THE PRODUCT IN THE SAME PACKAGE, AND THE SAMPLE CANNOT BE RETURNED. REPLACE THE CONNECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1048051 BD Q-SYTE CLOSED LUER ACCESS DEVICE SET, ADMINISTRATION, INTRAVASCULAR FPA BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3152068 00382903851003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown