BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIP CLOSURE WITH POUCH

    MDR report key: 2270794 · Received September 21, 2011

    Report

    Report Number
    2270794
    Event Type
    Malfunction
    Date Received
    September 21, 2011
    Date of Event
    September 19, 2011
    Report Date
    September 20, 2011
    Manufacturer
    MEDICAL ACTION INDUSTRIES, INC.
    Product Code
    NNI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US

    Narratives

    Description of Event or Problem · 1

    THE LAB SPECIMEN TRANSPORT BAGS FROM MEDICAL ACTION INDUSTRIES, INC. AND OTHER COMPANIES, ARE IMPRINTED WITH A LARGE OPAQUE ORANGE SQUARE, THE BIOHAZARD SYMBOL AND THE WORD "BIOHAZARD." WHEN SPECIMENS ARE PLACED IN THESE BAGS, THE IMPRINTING DESCRIBED ABOVE, OFTEN MAKES IT IMPOSSIBLE TO READ THE PATIENT INFORMATION ON THE SPECIMEN WITHIN THE BAG. THEREFORE, THROUGHOUT THE ENTIRE CHAIN OF HANDLING THESE SPECIMENS, THE PROPER IDENTIFICATION AND CONFIRMATION OF THE SPECIMEN WITHIN THESE BAGS, IS COMPROMISED. BUSY HOSPITAL STAFF WHO CANNOT EASILY READ THE PATIENT INFORMATION ON THE SPECIMEN IN THE BAGS, WILL OFTEN "ASSUME" THE IDENTITY OF THE SPECIMEN. THIS OBVIOUSLY HAS LEAD TO MANY INSTANCES OF SPECIMEN IDENTIFICATION ERRORS. FURTHERMORE, WHEN THE HOSPITAL STAFF DOES TAKE THE TIME AND EFFORT TO CONFIRM THE SPECIMEN IDENTIFICATION, THIS CAN OFTEN ONLY IS ACCOMPLISHED BY OPENING THE BAG AND REMOVING THE SPECIMEN. THIS ACTION, OF COURSE, LEADS TO STAFF EXPOSURE TO BIOHAZARDS. THE SIMPLE SOLUTION TO THESE PROBLEMS WOULD BE TO MAKE THE BIOHAZARD LABELING ON THESE SPECIMEN BAGS SMALLER AND TRANSPARENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIP CLOSURE WITH POUCH LAB SPECIMEN TRANSPORT BAG NNI MEDICAL ACTION INDUSTRIES, INC. 4914.ORG *

    Patients

    Seq Age Sex Outcome Treatment
    1 *