BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCT SPECIALIZED TRACH

    MDR report key: 5275496 · Received December 8, 2015

    Report

    Report Number
    2936999-2015-01049
    Event Type
    Malfunction
    Date Received
    December 8, 2015
    Report Date
    November 17, 2015
    Manufacturer
    SHILEY
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN/MEDTRONIC REFERENCE NUMBER (B)(4). THE CUSTOMER RETURNED SEVEN BOXES OF UNUSED CUSTOMIZED CUFFLESS SINGLE CANNULA TRACHEOSTOMY TUBE PART NUMBER M8SCT FOR EVALUATION. THE REPORTED ISSUE COULD NOT BE CONFIRMED IN ALL SAMPLES.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT OBSERVING A SEAM IN THE CURVED PORTION OF THE TRACHEOSTOMY TUBE THAT HAS A LIP/EDGE THAT IS RUBBING AGAINST THE PATIENT TRACHEA. HE SAID THAT THERE IS PAIN AND DISCOMFORT, BUT THAT THERE WAS NO BLEEDING OR RUPTURES OF THE TRACHEA. THE CUSTOMER DID NOT REPORT ANY REQUIRED INTERVENTION SUCH AS RECANNULATION OF THE PATIENT WITH ANOTHER TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803970 SCT SPECIALIZED TRACH TRACHEOSTOMY TUBE JOH SHILEY MSCT 15I0573JZX

    Patients

    Seq Age Sex Outcome Treatment
    1