BEUDAMED
    FDA Adverse Event Death Summary report: N

    PORTEX ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT

    MDR report key: 972994 · Received April 25, 2007

    Report

    Report Number
    9610530-2007-00005
    Event Type
    Death
    Date Received
    April 25, 2007
    Date of Event
    April 4, 2007
    Report Date
    April 4, 2007
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL LTD.
    Product Code
    JOH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS HOSPITAL REPORTED TWO POSSIBLE CATALOG AND LOT NUMBERS. CATALOG NUMBERS ARE SAME FAMILY BUT TWO DIFFERENT SIZES (100/548/070 OR 100/548/080). RESULTS EVALUATION (OTHER): THE HOSP, INVOLVED WITH THIS INCIDENT, HAS STATED THAT THEY DO NOT FEEL THAT THIS DEVICE WAS RESPONSIBLE FOR THE PT OUTCOME. NO SIMILAR REPORTS ON THIS PRODUCT FAMILY.

    Description of Event or Problem · 1

    USER ALLEGES TRACHEOSTOMY TUBE WAS PLACED ON THE PT. SPO2 DROPPED, AND THE PT DIED ONE HOUR AFTER PERCUTANEOUS TRACHEOSTOMY. THE DR JUDGED THE PCT KIT WAS NOT RESPONSIBLE FOR THE PT'S DEATH. AFTER THE TUBE WAS PLACED FOLLOWING PCT PROCEDURE, SPO2 DROPPED SUDDENLY. THE DR INSERTED A TRACHEL TUBE, BUT COULD NOT DO SUCCESSFULLY. THE PT DIED AFTER 1 HR. THE DR STATED THAT HE HAD CONFIRMED BY THE TRACHEA CARTILAGE LOCATION AND INSERTED THE TUBE AT THE MIDLINE AND SUCCESSFULLY PLACED THE TUBE INTO THE TRACHEA THROUGH THE GUIDE WIRE. THE PT SEEMED TO HAVE BEEN VENTILATED AFTER INSERTION; HOWEVER, IT TURNED OUT THAT THE TUBE HAD BEEN INSERTED UNDER THE SKIN AND CAUSED SUBCUTANEOUS EMPHYSEMA. THE HOSP JUDGED THAT THE INCIDENT DID NOT RESULT FROM THE PRODUCT. EVENT OCCURRED AT REHABILITATION HOSPITAL IN ANOTHER COUNTRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORTEX ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT 73 JOH - TRACHESTOMY TUBE AND TUBE CUFF JOH SMITHS MEDICAL INTERNATIONAL LTD. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death