BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OTHER ACCESSORIES

    MDR report key: 24882085 · Received April 15, 2026

    Report

    Report Number
    8021545-2026-87409
    Event Type
    Malfunction
    Date Received
    April 15, 2026
    Date of Event
    March 17, 2026
    Report Date
    March 20, 2026
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER (ENTITY): ABBVIE INC, ESTABLISHMENT NAME: ABBVIE INC, COUNTRY: UNITED STATES OF AMERICA, STREET: 1 NORTH WAUKEGAN ROAD, CITY: NORTH CHICAGO, STATE, PROVINCE OR TERRITORY: IL, POST OFFICE OR 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. REQUEST WAS PERFORMED FOR ADDITIONAL INFORMATION INCLUDING LOT NUMBER; HOWEVER, LOT NUMBER WAS NOT PROVIDED. A COMPLAINT INVESTIGATION WAS INITIATED UNDER COMPLAINT INVESTIGATION. UNFORTUNATELY, NO SPECIFIC LOT NUMBER WAS IDENTIFIED, WHICH LIMITS THE ABILITY TO TRACE OR ANALYZE A PARTICULAR ITEM. INVESTIGATION IN PROGRESS. FDA REGISTRATION NUMBER: REPORTING SITE: 8021545, MANUFACTURING SITE: 8021545.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT FACED ISSUES WITH I INFUSION SET CANNULA CAME OUT OF THE PATIENT'S ABDOMEN ON (B)(6) 2026. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100235 OTHER ACCESSORIES Set, administration, intravascular FPA UNOMEDICAL A/S INFUSION DEVICES - UNKNOWN ICD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown