BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY

    MDR report key: 3893942 · Received June 9, 2014

    Report

    Report Number
    2936999-2014-00457
    Event Type
    Injury
    Date Received
    June 9, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 13, 2014
    Manufacturer
    COVIDIEN
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE TRACHEOSTOMY TUBE WAS RETURNED FOR INVESTIGATION. A VISUAL INSPECTION WAS PERFORMED AND FOUND THE TUBE WAS ASSEMBLED PROPERLY. AN INFLATION DEFLATION TEST WAS PERFORMED AND THE CUFF WORKED PROPERLY. THE SAMPLE WAS LEFT INFLATED FOR TWENTY FOUR HOURS AND AFTER THIS TIME NO DEFLATION WAS OBSERVED. THE SAMPLE WAS THEN SUBMERGED IN WATER AND NO LEAKS WERE OBSERVED. THE REPORTED FAILURE WAS NOT CONFIRMED IN THE RECEIVED SAMPLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE ASSOCIATED TO THIS REPORT IS EXPECTED TO BE RETURNED FOR ANALYSIS. IF THE SAMPLE IS RECEIVED, A SUMMARY OF THE INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER STATES: "THE SPOUSE OF THE PT REPORTS THAT THE CUFF KEPT ON DEFLATING. SHE HAD TO OVER INFLATE THE DEVICE WITH A VOLUME OF 15 ML OTHERWISE IT WOULD SLOWLY DEFLATE. SHE ALSO MENTIONED THAT SHE HAD TO RE-INFLATE THE DEVICE 3 TIMES DURING NIGHT. SHE CHANGES THE CANULA EVERY 5 DAYS. HOWEVER SHE RE-USED EACH CANULA A SECOND TIME AFTER 5 DAYS AND IT IS DURING THIS SECOND USE THAT THE DEVICE HAD ITS DEFLATING ISSUE. "COVIDIEN IS ATTEMPTING TO GATHER FURTHER DETAILS SURROUNDING THE CIRCUMSTANCES OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336681 SHILEY FENESTRATED LOW PRESSURE CUFFED JOH COVIDIEN 13D0062JZX

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention