BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NI

    MDR report key: 16875982 · Received May 5, 2023

    Report

    Report Number
    1416980-2023-02171
    Event Type
    Malfunction
    Date Received
    May 5, 2023
    Date of Event
    April 6, 2023
    Report Date
    July 26, 2023
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K180739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS DISCARDED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    UPDATE MADE TO D4: CATALOGUE #: 2R8538 (PREVIOUSLY SUBMITTED AS ASKU). UPDATE MADE TO G1: BAXTER HEALTHCARE - DOMINICAN REPUBLIC CARRETERA SANCHEZ KM 18.5 PARQUE INDUSTRIAL ITABO, PIISA HAINA, SAN CRISTOBAL 91000 DOMINICAN REPUBLIC (PREVIOUSLY SUBMITTED AS BAXTER HEALTHCARE CORPORATION). UPDATE MADE TO G4: PMA/510K # OR BLA #: K180739 (PREVIOUSLY SUBMITTED AS NI). ADDITIONAL INFORMATION H10: SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED ACCESS SET LEAKED WHERE THE CHAMBER AND TUBING CONNECT. THIS WAS IDENTIFIED DURING INFUSION WITH TOTAL PARENTERAL NUTRITION (TPN). THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1693324 NI SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown TOTAL PARENTERAL NUTRITION