BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGE CARDIOVASCULAR

    MDR report key: 25190779 · Received May 15, 2026

    Report

    Report Number
    3017540705-2026-00001
    Event Type
    Malfunction
    Date Received
    May 15, 2026
    Date of Event
    April 15, 2026
    Report Date
    May 15, 2026
    Manufacturer
    MED MICHIGAN HOLDINGS LLC / SURGE CARDIOVASCULAR
    Product Code
    DWF
    UDI-DI
    00817278012365
    PMA / PMN Number
    K081933
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER WHEN THE PRODUCT WAS TAKEN OUT OF THE BOX IT APPEARS THERE IS A PACKAGING PROBLEM WITH THE POUCH HAVING NO SEAL OR OPEN. THIS WAS IDENTIFIED PRIOR TO USE WITH NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132575 SURGE CARDIOVASCULAR ALPINE FEMORAL VENOUS CANNULA, DWF MED MICHIGAN HOLDINGS LLC / SURGE CARDIOVASCULAR FEM-V1024 09867-093025 00817278012365

    Patients

    Seq Age Sex Outcome Treatment
    1