BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD Q-SYTE LUER ACCESS SPLIT SEPTUM

    MDR report key: 12549871 · Received September 29, 2021

    Report

    Report Number
    9610847-2021-00472
    Event Type
    Malfunction
    Date Received
    September 29, 2021
    Date of Event
    August 10, 2021
    Report Date
    October 21, 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
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD WAS UNABLE TO PERFORM A THOROUGH INVESTIGATION AS NO SAMPLE, LOT, OR BATCH NUMBER WERE PROVIDED. DHR COULD NOT BE PERFORMED DUE TO UNKNOWN LOT#. THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED BD Q-SYTE LUER ACCESS SPLIT SEPTUM HAD LEAKAGE AT THE LUER CONNECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "4 INCIDENTS OF LEAKING FROM THE CONNECTION BETWEEN BD Q-SYTE AND SYRINGE WHEN BEING ACCESSED. NO FURTHER DETAILS KNOWN OF THE INCIDENT IN ICU ON THE 10TH. NOT REPORTED AT THE TIME DUE TO NOT BEING SURE IT WAS A PROBLEM WITH THE ACTUAL CONNECTOR OR THE WAY IN WHICH IT WAS USED. SINCE THEN MORE REPORTS WHICH HAVE LED US TO BE NOTIFIED."

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER ZIP: (B)(6). A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED BD Q-SYTE LUER ACCESS SPLIT SEPTUM HAD LEAKAGE AT THE LUER CONNECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "4 INCIDENTS OF LEAKING FROM THE CONNECTION BETWEEN BD Q-SYTE AND SYRINGE WHEN BEING ACCESSED. NO FURTHER DETAILS KNOWN OF THE INCIDENT IN ICU ON THE 10TH. NOT REPORTED AT THE TIME DUE TO NOT BEING SURE IT WAS A PROBLEM WITH THE ACTUAL CONNECTOR OR THE WAY IN WHICH IT WAS USED. SINCE THEN MORE REPORTS WHICH HAVE LED US TO BE NOTIFIED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1445250 BD Q-SYTE LUER ACCESS SPLIT SEPTUM INTRAVASCULAR ADMINISTRATION SET FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 385100 UNKNOWN 30382903851004

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown