BEUDAMED
    FDA Adverse Event Other Summary report: N

    5QT.CNT.W/COUNTR BLNC DR RED20

    MDR report key: 3843797 · Received May 23, 2014

    Report

    Report Number
    1424643-2014-00005
    Event Type
    Other
    Date Received
    May 23, 2014
    Date of Event
    April 29, 2014
    Report Date
    April 29, 2014
    Manufacturer
    COVIDIEN
    Product Code
    MMK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY, UPON COMPLETION THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(4) 2014 THAT A CUSTOMER HAD AN ISSUE WITH A SHARPS CONTAINER. THE CUSTOMER REPORTS SHARPS CONTAINERS HAD BEEN COLLECTED FROM THE FLOOR AND HAD BEEN SENT DOWN TO BE AUTOCLAVED THEN DISPOSED OF AS PER THE HOSPITAL PROTOCOL. THE CONTAINER WAS AUTOCLAVED AND LEFT ON THE FLOOR BY A PREVIOUS EMPLOYEE AND ANOTHER EMPLOYEE CAME TO PICK UP THIS CONTAINER AND WAS STUCK FROM A NEEDLE POKING FROM THE MIDDLE BOTTOM OF THE CONTAINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307976 5QT.CNT.W/COUNTR BLNC DR RED20 SHARPS CONTAINER MMK COVIDIEN 8507SA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other