BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY

    MDR report key: 3180074 · Received June 13, 2013

    Report

    Report Number
    2936999-2013-00442
    Event Type
    Malfunction
    Date Received
    June 13, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 15, 2013
    Manufacturer
    COVIDIEN
    Product Code
    BTO
    PMA / PMN Number
    K810106
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CUSTOMER STATES: DURING USE ON A PATIENT AT HOSPITAL, WHEN THE DOCTOR ATTEMPTED ROUTINE TRACH REPLACEMENT, THE CUFF COULD NOT BE DEFLATED EASILY. THE CUSTOMER REPORTED THAT THE DOCTOR MANAGED TO REMOVE IT FROM PATIENT. CUSTOMER REPORTED THAT FOLLOWING EXTUBATION, THE PHYSICIAN ATTEMPTED TO INFLATE THE CUFF BUT WAS UNSUCCESSFUL. CUSTOMER REPORTED NO FAULT OF THE TUBE CONFIRMED DURING USE JUST DURING EFFORTS TO REMOVE FOR ROUTINE REPLACEMENT. NO PATIENT HARM. PRE-TEST WAS DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268478 SHILEY SINGLE CANNULA TRACHEOSTOMY TUBE BTO COVIDIEN 120100449X

    Patients

    Seq Age Sex Outcome Treatment
    1