BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TISSEEL

    MDR report key: 11991192 · Received June 14, 2021

    Report

    Report Number
    11991192
    Event Type
    Malfunction
    Date Received
    June 14, 2021
    Date of Event
    February 26, 2021
    Report Date
    March 12, 2021
    Manufacturer
    BAXTER INTERNATIONAL INC.
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PRODUCT IS PACKAGED IN TWO SEPARATE PEEL POUCHES. APPLICATION TIPS PACKAGE INDICATES THAT THE CONTENTS ARE STERILE. MEDICATION PACKAGE INDICATES THAT THE TWO SOLUTIONS LOCATED IN THE DUPLEX SYRINGE ARE STERILE, BUT DOES NOT INDICATE THAT THE ENTIRE CONTENTS OF THE PACKAGE ARE STERILE. IFU INSERT DOES SPEAK TO DELIVERING TO STERILE FIELD BUT NOT TO THE STERILITY OF THE PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    886972 TISSEEL SYRINGE, PISTON FMF BAXTER INTERNATIONAL INC.

    Patients

    Seq Age Sex Outcome Treatment
    1