BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD Q-SYTE¿ LUER ACCESS SPLIT SEPTUM (STAND-ALONE DEVICE)

    MDR report key: 18026966 · Received October 29, 2023

    Report

    Report Number
    2243072-2023-01959
    Event Type
    Malfunction
    Date Received
    October 29, 2023
    Date of Event
    October 11, 2023
    Report Date
    October 13, 2023
    Manufacturer
    BD MEDICAL, MEDICATION DELIVERY SOLUTIONS
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN FRANKLIN LAKES, NJ HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT UNSPECIFIED BD Q-STYLE EXTENSION SET THE CUSTOMER EXPERIENCED FLUID BLOCKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: IT WAS REPORTED THAT CLINICIAN AND/OR ANY PATIENTS HAVE ENCOUNTERED FLUID BLOCKAGE WHEN USING THE BD Q-STYLE EXTENSION SET. CLINICIAN EXPERIENCED: YES, I DID ENCOUNTER FLUID BLOCKAGE THAT LED TO INTERRUPTION OF THERAPY AND HARM WHEN I LAST USED THE BD Q-STYLE EXTENSION SET ON THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2138405 UNSPECIFIED BD Q-SYTE¿ LUER ACCESS SPLIT SEPTUM (STAND-ALONE DEVICE) INTRAVASCULAR ADMINISTRATION SET FPA BD MEDICAL, MEDICATION DELIVERY SOLUTIONS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown