BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO-VOLUME EXTENSION SET

    MDR report key: 18372747 · Received December 21, 2023

    Report

    Report Number
    1416980-2023-06680
    Event Type
    Malfunction
    Date Received
    December 21, 2023
    Date of Event
    September 17, 2023
    Report Date
    January 18, 2024
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPB
    UDI-DI
    00085412004846
    PMA / PMN Number
    K113227
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION MADE TO D5: OPERATOR OF DEVICE: HEALTH PROFESSIONAL (PREVIOUSLY SUBMITTED AS OTHER) CORRECTION MADE TO G1: DEVICE MANUFACTURER NAME: BAXTER HEALTHCARE - DOMINICAN REPUBLIC (PREVIOUSLY SUBMITTED AS BAXTER HEALTHCARE - HAINA) CORRECTION MADE TO G1: DEVICE MANUFACTURER ADDRESS 1: CARRETERA SANCHEZ KM 18.5 (PREVIOUSLY SUBMITTED AS PIISA INDUSTRIAL PARK ANTIGUA) CORRECTION MADE TO G1: DEVICE MANUFACTURER ADDRESS 2: PARQUE INDUSTRIAL ITABO, PIISA (PREVIOUSLY SUBMITTED AS CARRETERA SANCHEZ KM 18 1/2) ADDITIONAL INFORMATION WAS ADDED TO H3, H6 AND H10: H10: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE USER FACILITY SUBMITTED MEDWATCH MW5146010 FOR THIS EVENT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MICRO-VOLUME EXTENSION SET LEAKED AT THE FILTER. THIS OCCURRED DURING PATIENT INFUSION. 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
    2033957 MICRO-VOLUME EXTENSION SET FILTER, INFUSION LINE FPB BAXTER HEALTHCARE CORPORATION NA DR23B23024 00085412004846

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown