BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDINAL HEALTH

    MDR report key: 24304550 · Received February 10, 2026

    Report

    Report Number
    3004824601-2026-00016
    Event Type
    Malfunction
    Date Received
    February 10, 2026
    Date of Event
    January 30, 2026
    Report Date
    February 10, 2026
    Manufacturer
    HENG RONG PLASTIC PRODUCTS COMPANY
    Product Code
    NNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER INVESTIGATION OF RETURNED SAMPLE, IT WAS DETERMINED THAT THE ROOT CAUSE HAS PREVIOUSLY BEEN ADDRESSED THROUGH A PREVIOUS INVESTIGATION (DOCUMENTED WITHIN SCAR-19-00332) RELATED TO BAGS TEARING AT THE TOP ZIPPER PORTION. DUE TO THE LOT NUMBER NOT BEING PROVIDED, IT CANNOT BE DETERMINED IF THIS COMPLAINT WAS MADE BEFORE OR AFTER THE INVESTIGATION CORRECTIONS. WE WILL CONTINUE TO TRACK AND TREND FOR ANY ADDITIONAL REPORTED EVENTS. ADDITIONALLY, FROM THE CUSTOMER'S FEEDBACK IT APPEARS THAT THEY ARE USING THE DEFECTIVE PRODUCT INSTEAD OF DISCARDING IT PRIOR TO USE. CUSTOMER HAS BEEN ADVISED TO DISCARD ANY DEFECTIVE PRODUCTS PRIOR TO USE. NO REPORTED ADVERSE EVENTS WERE REPORTED.

    Description of Event or Problem · 0

    ON (B)(6) 2026, CUSTOMER EMAILED THAT THE RECENT BATCH THE CURRENTLY ARE USING ARE NOT OPENING PROPERLY. WE ARE UNABLE TO UNZIP THEM, OFTEN TEARING THE TOP OFF. WE HAVE SENT A FEW TO LAB WITHOUT BEING COMPLETELY CLOSED. NO ADVERSE EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116634 CARDINAL HEALTH STAT, SPECIMEN TRANSPORT BAG NNK HENG RONG PLASTIC PRODUCTS COMPANY CH6X9STAT

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown