BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX BLUE LINE SACETT SUCTION ABOVE THE CUFF TRACHEAL TUBE

    MDR report key: 2971988 · Received January 22, 2013

    Report

    Report Number
    2183502-2012-00683
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    December 19, 2012
    Report Date
    January 18, 2013
    Manufacturer
    SMITHS MEDICAL INTL LTD
    Product Code
    BTR
    PMA / PMN Number
    K081086
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    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 IN USE WITH PT WHEN OBSTRUCTION OF THE TUBE WAS NOTED. UPON EXAM OF THE TUBE THE REPORTER STATED THAT THE TUBE SHAFT APPEARED TO BE KINKED. THE USER FACILITY REMOVED THE PRODUCT FROM USE AND RE-INTUBATED THE PT WITH A REPLACEMENT PRODUCT. NO PERMANENT ADVERSE EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31528 PORTEX BLUE LINE SACETT SUCTION ABOVE THE CUFF TRACHEAL TUBE BTR - TRACHEAL TUBES BTR SMITHS MEDICAL INTL LTD NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK