BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OTHER ACCESSORIES

    MDR report key: 24787195 · Received April 6, 2026

    Report

    Report Number
    8021545-2026-89630
    Event Type
    Malfunction
    Date Received
    April 6, 2026
    Date of Event
    January 3, 2026
    Report Date
    March 6, 2026
    Manufacturer
    ABBVIE INC
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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 PATIENT FACED CANNULA ACCIDENTALLY PULLED OUT THE CANNULA EVENT ON (B)(6) 2026.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850815 OTHER ACCESSORIES Set, administration, intravascular FPA ABBVIE INC INFUSION DEVICES - UNKNOWN ICD 6013589

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown