BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OTHER ACCESSORIES

    MDR report key: 25180194 · Received May 15, 2026

    Report

    Report Number
    8021545-2026-07708
    Event Type
    Malfunction
    Date Received
    May 15, 2026
    Report Date
    April 16, 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

    / INITIAL 3 OF 3 BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE REPORTABLE MALFUNCTION. 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. 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 EXPERIENCED THREE INFUSION SETS CANNULAS HAD A LEAK ON FIRST EVENT- END OF (B)(6) 2026, SECOND EVENT -1ST WEEK OF (B)(6) 2026, THIRD EVENT- (B)(6) 2026.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334152 OTHER ACCESSORIES Set, administration, intravascular FPA ABBVIE INC INFUSION DEVICES - UNKNOWN ICD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown