BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY

    MDR report key: 4101597 · Received August 25, 2014

    Report

    Report Number
    2936999-2014-00789
    Event Type
    Injury
    Date Received
    August 25, 2014
    Date of Event
    August 5, 2014
    Report Date
    August 5, 2014
    Manufacturer
    COVIDIEN
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONE SAMPLE OF A TRACHEOTOMY TUBE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVIEWED THAT THE CUFF EXHIBITED A CUFF DISTORTION. INFLATION / DEFLATION PERFORMANCE TESTS WERE PERFORMED BY USING A 9CC SYRINGE OF AIR APPLIED TO THE CUFF, AND A DISTORTION WAS PRESENT. HOWEVER, A HERNIA OF THIS MAGNITUDE WOULD HAVE BEEN DETECTED DURING THE 100% INFLATE/DEFLATE TESTS, AND WOULD HAVE BEEN REMOVED FROM THE LOT. THE MALFUNCTION (HERNIA) CONDITION FOUND IN THE RECEIVED SAMPLE WAS NOT CONFIRMED AS RELATED TO MANUFACTURING PROCESS. THE ROOT CAUSE FOR THE CUSTOMER REPORTED MALFUNCTION COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO RETURN FOR AN EVALUATION. HOWEVER, IT HAS NOT BEEN YET REC'D. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER IN THE USA THAT, IMMEDIATELY AFTER INSERTION OF A M5.5PLC - CUSTOM TRACHEOSTOMY TUBE INTO AN (B)(6) MALE PATIENT, IF DEFLATED. THE PATIENT REQUIRES CONTINUOUS RESPIRATORY VENTILATION, AND NUTRITION VIA A J-TUBE, DUE TO CHRONIC ACUTE SPINAL MUSCULAR ATROPHY (SMA) TYPE I, BUT OTHERWISE HE IS IN GOOD HEALTH. ADDITIONALLY, IT WAS REPORTED THAT THE DEVICE WAS PRE-TESTED, AND LUBRICATED WITH SURGILUBE PRIOR TO INSERTION. THE UNIT WAS REPLACED WITH A SIMILAR ONE. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513904 SHILEY TRACHEOSTOMY TUBE JOH COVIDIEN 14G0450JZX

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Required Intervention