BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OTHER ACCESSORIES

    MDR report key: 24773173 · Received April 3, 2026

    Report

    Report Number
    8021545-2026-89618
    Event Type
    Malfunction
    Date Received
    April 3, 2026
    Report Date
    March 6, 2026
    Manufacturer
    ABBVIE INC
    Product Code
    FPA
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    003

    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. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT FACED ISSUE WITH INFUSION SETS AS THE CANNULAS QUICKLY CAME LOOSE FROM THE SKIN BECAUSE ADHESIVE EDGE OF THE CANNULAS DID NOT STAY IN PLACE REGULARLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833866 OTHER ACCESSORIES UNKNOWN FPA ABBVIE INC INFUSION DEVICES - UNKNOWN ICD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male