BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD Q-SYTE CLOSED LUER ACCESS DEVICE

    MDR report key: 20140971 · Received September 4, 2024

    Report

    Report Number
    1710034-2024-00979
    Event Type
    Malfunction
    Date Received
    September 4, 2024
    Date of Event
    July 29, 2024
    Report Date
    September 5, 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

    E. ADDRESS EXCEEDS CHARACTER LIMIT: NO. (B)(6). A COMPLAINT HISTORY CHECK WAS PERFORMED, AND THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF LEAKAGE WITH LOT # 3254532 AND MATERIAL # 385100. LOT 3254532 IS A FINAL PRODUCT LOT. Q-SYTE SUBASSEMBLIES USED IN THE FINAL LOT WERE BUILT UNDER PART NUMBER 8001498 LOT 3212022, 3212992 AND 3212990. DHR FOR LOT 3212022 WAS REVIEWED. NO DEVIATIONS WERE FOUND DURING THE MANUFACTURE OF THE SUBASSEMBLY BATCH. ROOT CAUSE COULDN'T BE DETERMINED DUE TO UNAVAILABILITY OF SAMPLE INFORMATION. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 385100 AND LOT NUMBER 3254532. 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. BASED ON THE AVAILABLE INFORMATION, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED.

    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: THE PATIENT'S CENTRAL VENOUS CATHETER WAS PLACED, AND THE SEPTUM NEEDLELESS CLOSED INFUSION CONNECTOR WAS REPLACED ON (B)(6) 2024, AND THE SEPTUM NEEDLELESS CLOSED INFUSION CONNECTOR WAS FOUND TO BE LEAKING IN THE MORNING OF (B)(6) 2024, AND WAS GIVEN A REPLACEMENT OF A PLAIN HEPARIN CAP, AND THE PATIENT HAD NO COMPLAINTS OF DISCOMFORT, FEVER, OR LOCALIZED REDNESS OR SWELLING AT THE PUNCTURE SITE, AMONG OTHER THINGS.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1833759 BD Q-SYTE CLOSED LUER ACCESS DEVICE SET, ADMINISTRATION, INTRAVASCULAR FPA BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3254532 00382903851003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown