BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 18015586 · Received October 26, 2023

    Report

    Report Number
    9610847-2023-00289
    Event Type
    Malfunction
    Date Received
    October 26, 2023
    Date of Event
    October 11, 2023
    Report Date
    October 13, 2023
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    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

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. D.4 DEVICE EXPIRATION DATE: UNKNOWN. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. H.4. DEVICE MANUFACTURE DATE: UNKNOWN H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE UNSPECIFIED BD Q-SYTE¿ LUER ACCESS SPLIT SEPTUM (STAND-ALONE DEVICE) THE CUSTOMER EXPERIENCED FLUID BLOCKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT CLINICIAN AND/OR ANY PATIENTS HAVE ENCOUNTERED FLUID BLOCKAGE WHEN USING THE BD Q-STYLE EXTENSION SET. VERBATIM: 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. -OTHER COMPLICATIONS: BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1674845 UNSPECIFIED BD Q-SYTE¿ LUER ACCESS SPLIT SEPTUM (STAND-ALONE DEVICE) INTRAVASCULAR ADMINISTRATION SET FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown