BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGE CARDIOVASCULAR

    MDR report key: 22206144 · Received June 13, 2025

    Report

    Report Number
    3017540705-2025-00001
    Event Type
    Malfunction
    Date Received
    June 13, 2025
    Date of Event
    May 15, 2025
    Report Date
    June 13, 2025
    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
    MI, US
    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 SEAL BEING 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
    899160 SURGE CARDIOVASCULAR ALPINE FEMORAL VENOUS CANNULA DWF MED MICHIGAN HOLDINGS LLC / SURGE CARDIOVASCULAR FEM-V1024 08999-021125 00817278012365

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown