BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY DISPOSABLE CANNULA LOW PRESSURE

    MDR report key: 2172610 · Received July 19, 2011

    Report

    Report Number
    2936999-2011-00488
    Event Type
    Injury
    Date Received
    July 19, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 21, 2011
    Manufacturer
    COVIDIEN/FORMERLY TYCO HEALTHCARE
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS RECEIVED AND EVALUATED BY MFG. VISUAL EXAMINATION REVEALED A CUT IN THE BODY OF THE CUFF. MFG HAS CONCLUDED THAT THIS TYPE OF CUT IS NOT RELATED TO THE MFG PROCESS. IF CUFF DAMAGE OF THIS MAGNITUDE WAS PRESENT AT TIME OF MFG, IT WOULD HAVE BEEN DETECTED DURING THE 100% INFLATE/DEFLATE TEST AND REMOVED FROM THE LOT. SUCH CUTS CAN BE INDICATIVE OF THE CUFF COMING IN CONTACT WITH A SHARP OBJECT/UTENSIL DURING USE AND HANDLING. NOTE: IT WAS REPORTED THAT THE CUFF HAD BEEN PRE-TESTED PRIOR TO INSERTION, AND FAILURE OCCURRED DURING AN UNSPECIFIED LENGTH OF TIME AFTER INSERTION.

    Description of Event or Problem · 1

    THE CALLER STATED THAT THE PT HAD AN 8DCT WITH A CUFF LEAK. THE TRACHEOSTOMY TUBE WAS INSERTED IN THE PT ON (B)(6) 2011. THE ISSUE REQUIRED RECANNULATION WITH ANOTHER 8DCT. THE CALLER STATED THAT THE CUFF WAS PRE-TESTED AND INFLATED USING MINIMAL LEAK TECHNIQUE. A LOT NUMBER WAS PROVIDED BUT THE EXPIRATION DATE IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY DISPOSABLE CANNULA LOW PRESSURE TRACHEOSTOMY TUBE JOH COVIDIEN/FORMERLY TYCO HEALTHCARE 0706002157

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention