BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSACROSS TRANSSEPTAL SHEATH

    MDR report key: 11824675 · Received May 14, 2021

    Report

    Report Number
    11824675
    Event Type
    Malfunction
    Date Received
    May 14, 2021
    Date of Event
    April 28, 2021
    Report Date
    May 7, 2021
    Manufacturer
    BAYLIS MEDICAL CO., INC.
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A LIVE BUG WAS FOUND INSIDE THE PACKAGE UPON OPENING THE STERILE PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720508 VERSACROSS TRANSSEPTAL SHEATH INTRODUCER, CATHETER DYB BAYLIS MEDICAL CO., INC. VXS85-35-63-45-D1 VXFG220121

    Patients

    Seq Age Sex Outcome Treatment
    1 27010 DA