BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY

    MDR report key: 3934269 · Received June 27, 2014

    Report

    Report Number
    2936999-2014-00558
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 29, 2014
    Manufacturer
    COVIDIEN
    Product Code
    JOH
    PMA / PMN Number
    K955680
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WAS PERFORMED ON ONE RETURNED SAMPLE OF A SHILEY PEDIATRIC TRACHEOSTOMY TUBE WAS RECEIVED FOR EVALUATION, AND NO LOT NUMBER WAS PROVIDED. VISUAL INSPECTION WAS PERFORMED, AND IT WAS OBSERVED THAT THE COMPONENTS WERE ASSEMBLED PROPERLY IN THE TUBE. INFLATION/DEFLATION TESTS WERE PERFORMED BY USING A 7CC SYRINGE OF AIR APPLIED TO THE CUFF. IT WAS OBSERVED THE CUFF HELD THE AIR, AND IT WAS LEFT INFLATED FOR 24 HOURS ACCORDING TO PROCESS INSTRUCTIONS. NO LEAKS OR DEFLATION WAS OBSERVED. ADDITIONALLY, THE DEVICE WAS SUBMERGED INTO A CONTAINER FILLED WITH WATER, AND NO LEAKS WERE OBSERVED. THE CUSTOMER REPORTED FAILURE MODE WAS NOT VERIFIED ON THE RECEIVED SAMPLE. (B)(4).

    Description of Event or Problem · 1

    A REPORT RECEIVED FORM (B)(6) STATED, DURING USE IN A PATIENT, AIR LEAKED FROM THE PILOT BALLOON. IT WAS REPORTED THAT THE PATIENT WAS RE-CANNULATED. THERE WAS NO PATIENT HARM REPORTED. THOUGH REQUESTED, LUBRICATIONS USE AND THE METHOD USED TO TEST THE BALLOON WAS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378125 SHILEY JOH COVIDIEN 5.5PDC

    Patients

    Seq Age Sex Outcome Treatment
    1