BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTEX TRACHEAL TUBE

    MDR report key: 3131434 · Received May 10, 2013

    Report

    Report Number
    2183502-2013-00215
    Event Type
    Injury
    Date Received
    May 10, 2013
    Date of Event
    April 5, 2013
    Report Date
    May 9, 2013
    Manufacturer
    SMITHS MEDICAL INTL LTD
    Product Code
    BTR
    PMA / PMN Number
    K083119
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MFR FOR DEVICE EVAL. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED THE MFR WILL FILE A F/U REPORT DETAILING THE RESULTS OF THE EVAL.

    Description of Event or Problem · 1

    USER FACILITY REPORTED THAT THE DEVICE WAS USED WITH A PT FOR COELIOSCOPY WHEN IT WAS OBSERVED THAT THE TRACHEAL TUBE BECAME KINKED, CAUSING AN ASYSTOLE. THE PT WAS TREATED FOR CARDIOPULMONARY ARREST WITH EPINEPHRINE/ADRENALIN AND PT WAS RESUSCITATED. NO PERMANENT ADVERSE EFFECTS TO PT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209381 PORTEX TRACHEAL TUBE BTR SMITHS MEDICAL INTL LTD NA 12120470

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other