BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON CO2 SAMPLING CANNULA A, 7FT 2IN

    MDR report key: 5607503 · Received April 26, 2016

    Report

    Report Number
    3011137372-2016-00109
    Event Type
    Malfunction
    Date Received
    April 26, 2016
    Date of Event
    April 15, 2016
    Report Date
    April 19, 2016
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CCK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QN#(B)(4). THE DEVICE SAMPLE WAS NOT RETURNED FOR EVALUATION AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4) THE SAMPLE WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER WAS NOT REPORTED BY THE CUSTOMER; THEREFORE, A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED. THE SUPPLIER REPORTS THAT THERE WERE TWO SIMILAR COMPLAINTS FOR THE ETCO2 CANNULA THAT WERE CAUSED BY CLOGGING OF THE CO2 LINES. AS THE CO2 LINE WAS OVER INSERTED TO THE STOPPER OF FOUR-HOLE CONNECTOR OR LUER CONNECTOR, THE LINE WAS EXTRUDED AND BECAME SMALLER, THUS THE GLUE CLOGGED THE LINE. THE ROOT CAUSE ANALYSIS REPORTED BY THE SUPPLIER: AS THE CO2 LINE WAS OVER INSERTED TO THE STOPPER OF FOUR-HOLE CONNECTOR OR LUER CONNECTOR, THE LINE WAS EXTRUDED AND THE INNER DIAMETER BECAME SMALLER, THUS THE GLUE CLOGGED THE LINE; THE INSERT DEPTH IS NOT DEFINED CLEARLY IN THE FIGURES OF THE WORK INSTRUCTION (WI) AND QUALITY INSPECTION PROCESS (QIP) FOR ADHESION; IN PRODUCTION, NOT ALL OF THE ETCO2 CANNULAS ARE FUNCTIONALLY INSPECTED BUT SAMPLING ONCE EVERY 3 HOURS. OTHER REMARKS: CORRECTIVE ACTION TAKEN: PLACE A SIGN ON SITE TO SHOW INSERT DEPTH; CHECK THE STORAGE AND PICK OUT THE OVER INSERTED CANNULAS; UPDATE WI AND QIP TO CONTROL INSERT DEPTH; TO SET UP A 100% OCCLUSION TEST FOR THE CANNULAS TO ENSURE THE FUNCTION SINCE NEXT ORDER, LOT# 160421.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT THE CONNECTION IS NOT ALLOWING ENOUGH OXYGEN.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT THE CONNECTION IS NOT ALLOWING ENOUGH OXYGEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262035 HUDSON CO2 SAMPLING CANNULA A, 7FT 2IN ANALYZER GAS, CARBON-DIOXIDE CCK TELEFLEX MEDICAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1