BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE EZ TEAR COLOR-CODED SPECIMEN TRANSPORT BAG WITH POCKET

    MDR report key: 23178681 · Received September 30, 2025

    Report

    Report Number
    23178681
    Event Type
    Malfunction
    Date Received
    September 30, 2025
    Date of Event
    January 21, 2025
    Report Date
    September 5, 2025
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    NNK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED TO ME THIS MORNING THAT THE NEWEST DARK BLUE BIO BAGS HAVE A COUPLE OF ISSUES. THE FIRST IS THAT WE CANNOT SEE THROUGH THE BAGS. THIS IS AN EXPOSURE ISSUE AS WE TRY TO LIMIT THE AMOUNT OF STAFF MEMBERS THAT HAVE TO REMOVE SAMPLES FROM THE BAGS. THE LESS PEOPLE EXPOSED THE BETTER. THESE BAGS DO NOT ALLOW AN EMPLOYEE TO KEEP THE SAMPLE IN THE BAG WHILE RECEIVING. SECONDLY RELATED TO THE SAME ISSUE, IS THAT SOMETIMES NURSES SEND UP MULTIPLE SPECIMEN TYPES IN THE SAME BAG, DRY SWABS HAVE BEEN MISSED AND THEN NEEDING RECOLLECTION DUE TO AN EMPLOYEE NOT SEEING IT IN THE BAG. THE SECOND ISSUE IS THAT THESE BAGS LEAK WHEN SENT UP WITH ICE. THE TEAR TAB IS WHERE THEY ARE LEAKING FROM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2104961 MEDLINE EZ TEAR COLOR-CODED SPECIMEN TRANSPORT BAG WITH POCKET CONTAINER, SPECIMEN MAILER AND STORAGE, NON-STERILE NNK MEDLINE INDUSTRIES, INC. DYND30269BT

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown