BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGE CARDIOVASCULAR

    MDR report key: 20763290 · Received November 22, 2024

    Report

    Report Number
    3017540705-2024-00003
    Event Type
    Malfunction
    Date Received
    November 22, 2024
    Date of Event
    August 25, 2023
    Report Date
    November 22, 2024
    Manufacturer
    MED MICHIGAN HOLDINGS LLC / SURGE CARDIOVASCULAR
    Product Code
    DWF
    UDI-DI
    00817278012389
    PMA / PMN Number
    K081933
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER ONE (1) UNSEALED POUCH AT THE BOTTOM.THIS WAS IDENTIFIED PRIOR TO USE. NO INJURY/DEATH WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1841794 SURGE CARDIOVASCULAR FEMORAL VENOUS CANNULA DWF MED MICHIGAN HOLDINGS LLC / SURGE CARDIOVASCULAR FEM-V1028 06510-021823 00817278012389

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown