BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIP CLOSURE WITH POUCH

    MDR report key: 2398741 · Received January 4, 2012

    Report

    Report Number
    2398741
    Event Type
    Malfunction
    Date Received
    January 4, 2012
    Date of Event
    September 19, 2011
    Report Date
    September 20, 2011
    Manufacturer
    MEDICAL ACTION INDUSTRIES, INC.
    Product Code
    LIO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US

    Narratives

    Description of Event or Problem · 1

    LAB SPECIMEN TRANSPORT BAGS FROM MEDICAL ACTION INDUSTRIES (CATALOG NUMBER 4914.ORG), AND OTHER COMPANIES BAGS ARE IMPRINTED WITH A LARGE OPAQUE ORANGE SQUARE WITH 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 OF 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 AND OFTEN "ASSUME" THE IDENTITY OF THE SPECIMEN. THIS OBVIOUSLY HAS LEAD TO MANY INSTANCES OF SPECIMEN IDENTIFICATION ERRORS. FURTHERMORE, THE HOSPITAL STAFF HAS TO TAKE THE TIME AND EFFORT TO CONFIRM THE SPECIMEN IDENTIFICATION. THIS CAN ONLY BE ACCOMPLISHED BY OPENING THE BAG AND REMOVING THE SPECIMEN. THIS ACTION, OF COURSE, LEADS TO STAFF EXPOSURE TO BIOHAZARDS. THE SIMPLE SOLUTION TO THIS PROBLEM WOULD BE TO MAKE THE BIOHAZARD LABEL SMALLER AND TRANSPARENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *