BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY PEDIATRIC

    MDR report key: 2113762 · Received June 2, 2011

    Report

    Report Number
    2936999-2011-00368
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 16, 2011
    Manufacturer
    COVIDIEN/FORMERLY TYCO
    Product Code
    JOH
    PMA / PMN Number
    K945513
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE TUBE IS UNKNOWN, AND THE TUBE WAS DISCARDED. NO CONCLUSIONS CAN BE DRAWN WITHOUT THE DEVICE FOR EVALUATION. INFORMATION HAS BEEN ADDED TO THE DATABASE FOR TRENDING PURPOSES.

    Description of Event or Problem · 1

    THE CALLER STATED THAT THERE WAS AN ISSUE USING THE PASSEY MUIR VALVE WITH THE TRACHEOSTOMY TUBE. SHE STATED THAT THE VALUE WOULD NOT CONNECT PROPERLY AND THAT SHE WAS NOT ABLE TO GET THE PASSY MUIR VALVE ON. SHE CHANGED OUT THE PATIENT'S TRACHEOSTOMY TUBE AND WAS ABLE TO FIT THE PASSY MUIR VALVE ON A NEW UNSPECIFIED TUBE. THE CALLER STATED SHE DID NOT SAVE THE TRACHEOSTOMY TUBE AND SHE DID NOT KNOW IT'S LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY PEDIATRIC TRACHEOSTOMY TUBE JOH COVIDIEN/FORMERLY TYCO

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention