BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD Q-SYTE LUER ACCESS SPLIT SEPTUM

    MDR report key: 11186690 · Received January 18, 2021

    Report

    Report Number
    9610847-2021-00025
    Event Type
    Malfunction
    Date Received
    January 18, 2021
    Date of Event
    December 7, 2020
    Report Date
    April 14, 2021
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    30382903851004
    PMA / PMN Number
    K013621
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: 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. SINCE, AN INVESTIGATION COULD NOT BE PERFORMED BD WAS UNABLE TO DETERMINE A POSSIBLE ROOT CAUSE. THE MANUFACTURING FACILITY HAS BEEN NOTIFIED OF THIS INCIDENT AND THE FINDINGS. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 BD Q-SYTE LUER ACCESS SPLIT SEPTUMS LEAKED. "THIS INITIAL REPORT IS BEING REPORTED BY LPCH ON BEHALF OF THE PATIENT. A 68-YEAR-OLD FEMALE PATIENT WITH LPCH ID (B)(6) REPORTED ON (B)(6) 2020 THAT SHE HAS HAD THREE FAULTY BD Q-SYTE LUER AND HAS HAD TO CHANGE THEM DUE TO LEAKS. THE PATIENT REPORTED SHE WASN¿T SURE IF IT WAS THIS OR THE LINES HOWEVER WHEN SHE CHANGED THE BD Q-SYTE LUER IT STOPPED SO ASSUMES IT¿S THIS. BATCH NUMBER- 9305462 AND EXPIRY DATE - 30/09/24. AT THE TIME OF THE REPORT THE OUTCOME OF THE EVENT WAS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED".

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 3 BD Q-SYTE LUER ACCESS SPLIT SEPTUMS LEAKED. "THIS INITIAL REPORT IS BEING REPORTED BY LPCH ON BEHALF OF THE PATIENT. A (B)(6) FEMALE PATIENT WITH LPCH ID ¿(B)(4) REPORTED ON (B)(6) 2020 THAT SHE HAS HAD THREE FAULTY BD Q-SYTE LUER AND HAS HAD TO CHANGE THEM DUE TO LEAKS. THE PATIENT REPORTED SHE WASN¿T SURE IF IT WAS THIS OR THE LINES HOWEVER WHEN SHE CHANGED THE BD Q-SYTE LUER IT STOPPED SO ASSUMES IT¿S THIS. BATCH NUMBER- 9305462 AND EXPIRY DATE - 30/09/24. AT THE TIME OF THE REPORT THE OUTCOME OF THE EVENT WAS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83885 BD Q-SYTE LUER ACCESS SPLIT SEPTUM INTRAVASCULAR ADMINISTRATION SET FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 385100 9305462 30382903851004

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR