BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OTHER ACCESSORIES

    MDR report key: 24883725 · Received April 15, 2026

    Report

    Report Number
    8021545-2026-87097
    Event Type
    Malfunction
    Date Received
    April 15, 2026
    Report Date
    March 18, 2026
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    E1: NAME: ABBVIE INC. COUNTRY: UNITED STATES OF AMERICA. STREET: 1 NORTH WAUKEGAN ROAD. CITY: NORTH CHICAGO. STATE: IL. ZIP CODE: 60064. BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER. REPORTING SITE: 8021545. MANUFACTURING SITE: 8021545.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT FACED INFUSION SET LEAKAGE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318511 OTHER ACCESSORIES Set, administration, intravascular FPA UNOMEDICAL A/S INFUSION DEVICES - UNKNOWN ICD 6014432

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male