BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON ET TUBE, UNCUFFED, PED-SOFT, 2.5MM

    MDR report key: 4202394 · Received September 15, 2014

    Report

    Report Number
    3003898360-2014-00710
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    July 25, 2014
    Report Date
    August 22, 2014
    Manufacturer
    TELEFLEX
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL FUNCTIONAL, AND DIMENSIONAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT IS IN PROGRESS. A DHR (DEVICE HISTORY RECORD) REVIEW WAS PERFORMED ON THE PRODUCT ET TUBE, UNCUFFED, PED-SOFT, 2.5. THE DHR INVESTIGATION DID NOT SHOW ISSUES RELATED TO THE REPORTED COMPLAINT. THE REPORTED LOT#: 01L1300255 WAS MANUFACTURED ON 11/21/2013. A DOCUMENT ASSESSMENT ((B)(4)) WAS CONDUCTED AND NO CHANGES WERE REQUIRED. AT THIS TIME SINCE THE DEVICE SAMPLE IS IN THE PROCESS OF BEING INVESTIGATED IT IS NOT POSSIBLE TO DETERMINE THE SOURCE OF THE DEFECT REPORTED, CONFIRM THE COMPLAINT, DETERMINE A ROOT CAUSE AND PROVIDE A CORRECTIVE ACTION. ONCE THE SAMPLE INVESTIGATION IS COMPLETE THE COMPLAINT WILL BE UPDATED ACCORDINGLY.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THAT THE TUBE APPEARS TO HAVE A PIECE OF PLASTIC AT THE DISTAL TIP THAT IS CAUSING AN OCCLUSION. THE ALLEGED DEFECT WILL NOT ALLOW THE SUCTION CATHETER TO PASS COMPLETELY THROUGH THE ENDOTRACHEAL TUBE. THE ALLEGED DEFECT WAS DISCOVERED DURING PRE-TEST AND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569374 HUDSON ET TUBE, UNCUFFED, PED-SOFT, 2.5MM ENDOTRACHEAL TUBE BTR TELEFLEX 01L1300255

    Patients

    Seq Age Sex Outcome Treatment
    1 SUCTION CATHETER