BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY

    MDR report key: 3181583 · Received June 14, 2013

    Report

    Report Number
    2936999-2013-00444
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 15, 2013
    Manufacturer
    COVIDIEN
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    CALLER IS A TRACH PT'S FATHER. CALLER STATES THIS ITEM WAS PLACED IN THE PT ON (B)(6) 2013. THE ITEM WAS PRE-TESTED PER THE DFU BEFORE INSERTION. A BIT OF VASELINE TYPE LUBRICATION WAS USED. THE PT HAS NO ANOMALIES. CALLER STATED THAT ON (B)(6) 2013 IT WAS NOTICED THAT THE ITEM WAS NOT HOLDING AIR PRESSURE. THE PILOT TUBE BECAME DEFLATED. CALLER DISCOVERED AN AIR LEAK IN THE PILOT BALLOON. CALLER STATED THAT HE HAS REPAIRED THE PILOT BALLOON LEAK TEMPORARILY WITH A REPAIR KIT. THE ITEM IS STILL IN THE PT, HOWEVER, RECANNULATION WILL BE REQUIRED BEFORE THE SCHEDULED 30 DAYS REPLACEMENT. CALLER CONFIRMS AT THE TIME OF THE CALL THE ITEM WAS STILL IN USE BY THE PT BUT THERE IS A PLAN FOR THE TUBE TO BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270921 SHILEY DISPOSABLE CANNULA LOW PRESSURE CUF JOH COVIDIEN 12J0269JZX

    Patients

    Seq Age Sex Outcome Treatment
    1