BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD Q-SYTE LUER ACCESS SPLIT SEPTUM

    MDR report key: 17107708 · Received June 12, 2023

    Report

    Report Number
    9610847-2023-00142
    Event Type
    Malfunction
    Date Received
    June 12, 2023
    Date of Event
    April 13, 2023
    Report Date
    May 16, 2023
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    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

    H6: INVESTIGATION SUMMARY THERE WAS NO SAMPLE OR PHOTO AVAILABLE TO BD FOR EVALUATION. THEREFORE, BD WAS UNABLE TO PERFORM A THOROUGH INVESTIGATION TO VERIFY THE REPORTED ISSUE. LOT 1237313 IS A FINAL PRODUCT LOT. Q-SYTE SUBASSEMBLIES USED IN THAT FINAL LOT WERE BUILT UNDER PART NUMBER 8001498 LOTS 1202055, 1202979 AND 1218602. DHR FOR LOT 1202055 WAS REVIEWED. THE LOT WAS BUILT, AND BULK PACKAGED ON QFA LINE 5 FROM (B)(6) 2021 THROUGH (B)(6) 2021 FOR A TOTAL QUANTITY OF (B)(4) UNITS. NO RELATED DEVIATIONS WERE FOUND DURING THE MANUFACTURE OF THE SUBASSEMBLY BATCH. QN# (B)(4). WAS INITIATED FOR LOW PUSH DURING THE BUILT OF THIS LOT NUMBER, WHICH COULD POTENTIALLY BE RELATED TO THIS COMPLAINT. NO PROCESS DEVIATIONS WERE FOUND. DHR FOR LOT 1202979 WAS REVIEWED. THE LOT WAS BUILT, AND BULK PACKAGED ON QFA LINE 5 FROM (B)(6) 2021 THROUGH (B)(6) 2021 FOR A TOTAL QUANTITY OF (B)(4) UNITS. NO RELATED QUALITY ISSUES OR DEVIATIONS WERE FOUND DURING THE MANUFACTURE OF THE SUBASSEMBLY BATCH. DHR FOR LOT 1218602 WAS REVIEWED. THE LOT WAS BUILT, AND BULK PACKAGED ON QFA LINE 5 FROM (B)(6) 2021 THROUGH (B)(6) 2021 FOR A TOTAL QUANTITY OF (B)(4) UNITS. NO RELATED QUALITY ISSUES OR DEVIATIONS WERE FOUND DURING THE MANUFACTURE OF THE SUBASSEMBLY BATCH. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD Q-SYTE LUER ACCESS SPLIT SEPTUM LEAKAGE OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM CHINESE: USAGE TIME: (B)(6) 2023 PURPOSE: TO CONNECT THE INFUSION CONNECTOR FUNCTION BASIS: INFUSION THERAPY. BECAUSE THE THREAD IS TOO SHORT, THE CONNECTOR PART OF THE INFUSION SET IS LEAKING AND BLEEDING WHEN USED. RESULTING IN INSUFFICIENT FLUID INPUT MEASUREMENT, BLOOD PRESSURE DROP, PATIENTS AGITATED, AFFECTING THE CONDITION. TIMELY REPLACEMENT OF ANOTHER NEEDLE FREE CONNECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    957316 BD Q-SYTE LUER ACCESS SPLIT SEPTUM INTRAVASCULAR ADMINISTRATION SET FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 385100 1237313 00382903851003

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown