BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OTHER ACCESSORIES

    MDR report key: 25091515 · Received May 6, 2026

    Report

    Report Number
    8021545-2026-05865
    Event Type
    Malfunction
    Date Received
    May 6, 2026
    Report Date
    April 8, 2026
    Manufacturer
    ABBVIE INC
    Product Code
    FPA
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. REQUEST WAS PERFORMED FOR ADDITIONAL INFORMATION INCLUDING SERIAL NUMBER; HOWEVER, SERIAL NUMBER AND DATE OF EVENT 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. 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 STATES THAT HER TUBING WAS RIPPED OUT OF HER CANNULA WHEN SHE DROPPED THE PUMP AND SHE REMOVED THE CANNULA BUT FEELS LIKE SOMETHING STRAIGHT IS UNDERNEATH THE SKIN AT THE INFUSION SITE, HOWEVER NO HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526493 OTHER ACCESSORIES Set, administration, intravascular FPA ABBVIE INC INFUSION DEVICES - UNKNOWN ICD 6014463

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female