BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTRAL VENOUS CATHETER

    MDR report key: 25104623 · Received May 6, 2026

    Report

    Report Number
    MW5187833
    Event Type
    Injury
    Date Received
    May 6, 2026
    Report Date
    May 2, 2026
    Manufacturer
    UNKNOWN
    Product Code
    SEF
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    003
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT REPORTED THEY WERE HOSPITALIZED FOR LOW PLATELETS AND UNSPECIFIED BLOOD INFECTION, BUT NOT REPORTED AS A CVC (CENTRAL VENOUS CATHETER) INFECTION, IN EARLY (B)(6) 2026, AND THEY HAD TO HAVE THEIR IV LINE REPLACED. MD IS AWARE OF BOTH HOSPITALIZATION AND INFECTION. NO FURTHER INFORMATION, DETAILS OR DATES AVAILABLE. EXACT DATE OF ADMITTANCE/DISCHARGE OR LENGTH OF HOSPITALIZATION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580131 CENTRAL VENOUS CATHETER CENTRAL VENOUS CATHETER WITH MANUAL INSERTION SYSTEM SEF UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization WINREVAIR SDV 4MG.