BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY

    MDR report key: 4101565 · Received August 25, 2014

    Report

    Report Number
    2936999-2014-00791
    Event Type
    Injury
    Date Received
    August 25, 2014
    Date of Event
    July 31, 2014
    Report Date
    August 6, 2014
    Manufacturer
    COVIDIEN
    Product Code
    JOH
    PMA / PMN Number
    K945513
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED TRACHEAL TUBE WAS RECEIVED AND EVALUATED FOR THE REPORTED "CHIPPED/CRACKED CONNECTOR". THE FAILURE MODE WAS CONFIRMED IN THE RECEIVED SAMPLE. THE SAMPLE SHOWED DAMAGE IN THE PART BETWEEN THE CONNECTOR AND THE FLANGE. THE REPORTED FAILURE MODE CAN BE REPRODUCED BUT NOT REPLICATED UNDER A CHANGE OF PARAMETERS. THIS MARK IS CONSIDERED AN ISOLATED CONDITION. (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR AN EVALUATION. HOWEVER, IT HAS NOT YET BEEN RETURNED. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER IN (B)(6) THAT, DURING PATIENT USE OF A PEDIATRIC TRACHEOSTOMY TUBE, THE DEVICE CONNECTOR'S BASE WAS FOUND TO BE CRACKED. THE REQUIREMENT OF RE-CANNULATION IS UNKNOWN. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513844 SHILEY TRACHEOSTOMY TUBE JOH COVIDIEN UNK

    Patients

    Seq Age Sex Outcome Treatment
    1