BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON ET TUBE, UNCUFFED, 2.5

    MDR report key: 3955659 · Received June 12, 2014

    Report

    Report Number
    3003898360-2014-00390
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    May 30, 2014
    Report Date
    June 2, 2014
    Manufacturer
    TELEFLEX
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL, FUNCTIONAL, AND DIMENSIONAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RETURNED. PER DHR, THE PRODUCT WAS MANUFACTURED ON 09/05/2012. THE DHR INVESTIGATION DID NOT SHOW ISSUES RELATED TO COMPLAINT. A DOCUMENT ASSESSMENT (FMEA) WAS CONDUCTED AND NO CHANGES WERE REQUIRED. THE COMPLAINT CAN NOT BE CONFIRMED SINCE THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION, THEREFORE, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE FOR THE DEFECT REPORTED AND A CORRECTIVE ACTION FOR IT. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATING COMPLAINTS.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THAT THE DEVICE HAD A BLOCKAGE AT THE DISTAL END OF THE TUBE. THE CUSTOMER ALLEGES THAT A SUCTION CATHETER COULD NOT BE PASSED THROUGH THE ENDOTRACHEAL TUBE. THE ENDOTRACHEAL TUBE WAS BEING PRE-TESTED PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348144 HUDSON ET TUBE, UNCUFFED, 2.5 ENDOTRACHEAL TUBE BTR TELEFLEX 01H1200518

    Patients

    Seq Age Sex Outcome Treatment
    1 KIMBERLY CLARK SUCTION CATHETER, 6FR