BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX RSP TRACHEAL TUBE HOLDERS

    MDR report key: 3040569 · Received March 12, 2013

    Report

    Report Number
    2183502-2013-00085
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Date of Event
    February 6, 2013
    Report Date
    March 8, 2013
    Manufacturer
    SMITHS MEDICAL INTL LTD
    Product Code
    JAY
    PMA / PMN Number
    K802675
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    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 LOCK MECHANISM ON THE ENDOTRACHEAL TUBE WAS TOO TIGHT TO ALLOW PASSAGE OF A SUCTION CATHETER. AS A RESULT IT WAS NECESSARY TO RELEASE THE LOCKING MECHANISM TO ALLOW PASSAGE OF THE SUCTION CATHETER. NO PERMANENT ADVERSE EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104229 PORTEX RSP TRACHEAL TUBE HOLDERS JAY - BREATHING TUBE SUPPORT JAY SMITHS MEDICAL INTL LTD NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK