BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TISSUE-TEK®

    MDR report key: 19031495 · Received April 3, 2024

    Report

    Report Number
    19031495
    Event Type
    Malfunction
    Date Received
    April 3, 2024
    Date of Event
    September 12, 2023
    Report Date
    October 16, 2023
    Manufacturer
    SAKURA FINETEK U.S.A., INC.
    Product Code
    NNK
    UDI-DI
    00615233078391
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    MESH BIOPSY BAGS ARE USED TO HOLD TISSUES WHEN GROSSING TO KEEP THEM SAFE, BEFORE BEING INSERTED INTO CASSETTES. THE CURRENT MESH BAGS ARE TEARING APART AT THE EDGES WHEN OPENING THEM TO PUT TISSUES IN AND NOT HOLDING THEIR SHAPE. THIS GIVES TISSUES THE POTENTIAL TO BE LOST OUT THE SIDE OF THESE BAGS. THERE HAS BEEN AN INCREASED NUMBER OF BAGS TEARING APART AT THE EDGES CAUSING THE GROSSING TECH TO THROW THEM AWAY OR IF THEY ARE NOT CAUGHT AT THE TIME A POTENTIAL FOR LOSS OF IRRETRIEVABLE TISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1448076 TISSUE-TEK® CONTAINER, SPECIMEN MAILER AND STORAGE, NON-STERILE NNK SAKURA FINETEK U.S.A., INC. 4223 00615233078391

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown