BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY LOW PRESSURE CUFFED

    MDR report key: 2223931 · Received August 17, 2011

    Report

    Report Number
    2936999-2011-00493
    Event Type
    Injury
    Date Received
    August 17, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 19, 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
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS RECEIVED AND EVALUATED. VISUAL EXAMINATION REVEALED A CUT TO THE BODY OF THE CUFF. MFG HAS CONCLUDED THAT THIS TYPE OF DAMAGE IS NOT RELATED TO THE MFG PROCESS. IF 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. THIS TYPE OF DAMAGE CAN BE INDICATIVE OF THE CUFF COMING IN CONTACT WITH A SHARP OBJECT OR ANATOMICAL ANOMALIES OF THE PT'S AIRWAY SUCH AS SHARP EDGES OF CARTILAGE. IT WAS NOTED THAT THE USER PERFORMED PRE-INFLATION TESTING OF THE CUFF TO ENSURE THE CUFF HOLDS AIR, AND CONTINUED THEN TO INSERT IN THE PT WHICH MAY SUGGEST THAT DAMAGE OCCURRED DURING USE AND HANDLING.

    Description of Event or Problem · 1

    THE CALLER STATED THAT THEY HAD A TRACHEOSTOMY TUBE WITH A LEAK, AND THAT THE SPOT WHERE THE LEAK WAS, COULD NOT BE IDENTIFIED. THE TUBE WAS IN USE BETWEEN 1.5 AND 2 HOURS. THE ISSUE REQUIRED RECANNULATION THAT WAS NOT A PART OF ROUTINE TRACH CHANGING. THE CALLER STATED THE CUFFS ARE PRE-TESTED, AND THE CUFF ON THE FAILED TRACH WAS INFLATED WITH 12 CC S AIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY LOW PRESSURE CUFFED TRACHEOSTOMY TUBE JOH COVIDIEN/FORMERLY TYCO HEALTHCARE 1010001457

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention