BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON ET TUBE,CF,4.5MM

    MDR report key: 3869109 · Received April 29, 2014

    Report

    Report Number
    3003898360-2014-00265
    Event Type
    Malfunction
    Date Received
    April 29, 2014
    Date of Event
    February 21, 2014
    Report Date
    April 8, 2014
    Manufacturer
    TELEFLEX
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FROM THE PICTURE, IT WAS OBSERVED A "TORN PACKAGE." NO OTHER DEFECTS WERE OBSERVED. PER DHR (DEVICE HISTORY RECORD) THE PRODUCT ET TUBE, CF,4.5, LOT #01H1300308 WAS MANUFACTURED ON 08/29/2013. THE DHR INVESTIGATION DID NOT SHOW ISSUES RELATED TO COMPLAINT. A DOCUMENT ASSESSMENT (FMEA) WAS CONDUCTED AND NO CHANGES WERE REQUIRED. FROM THE PICTURE IT WAS OBSERVED A "TORN PACKAGE", THE COMPLAINT CAN NOT BE CONFIRMED AND A CONCLUSIVE ROOT CAUSE CAN NOT BE DETERMINED SINCE THE SAMPLE WAS NOT AVAILABLE. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATING COMPLAINTS.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE PACKAGE IS TORN/BROKEN. THE ALLEGED ISSUE WAS DETECTED DURING INCOMING INSPECTION BY (B)(4) DISTRIBUTOR (IMJ). QUANTITY REPORTED IS TWO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256014 HUDSON ET TUBE,CF,4.5MM ENDOTRACHEAL TUBE BTR TELEFLEX 01H1300308

    Patients

    Seq Age Sex Outcome Treatment
    1