BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON CORR-A-FLEX TUBING, 100 FT ROLL

    MDR report key: 3851579 · Received March 25, 2014

    Report

    Report Number
    3004365956-2014-00140
    Event Type
    Malfunction
    Date Received
    March 25, 2014
    Date of Event
    January 30, 2014
    Report Date
    March 6, 2014
    Manufacturer
    TELEFLEX
    Product Code
    BZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS RECEIVED BY THE MFR, BUT THE INVESTIGATION IS INCOMPLETE AT THE TIME OF THIS REPORT. THE DEVICE HISTORY RECORD (DHR) OF NL BATCH NUMBER 02L1303011 HAS BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND WHICH COULD POTENTIALLY BE RELATED TO THIS COMPLAINT. ANY NON CONFORMANCE REPORTS WERE ORIGINATED FOR THE LOT IN QUESTION THAT CAN BE ASSOCIATED TO THE COMPLAINT REPORTED. THE DHR SHOWS THAT THE PRODUCT WAS ASSEMBLED AND INSPECTED ACCORDING TO OUR SPECIFICATIONS.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGED THAT THE TUBING IS STIFF AND NOT PLIABLE AND DETACHES FROM THE PT'S MASK ON PT MOVEMENT OR WHEN MASK ADJUSTED. THE TUBING WAS CHANGED OUT. NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173880 HUDSON CORR-A-FLEX TUBING, 100 FT ROLL CORRUGATED TUBING BZO TELEFLEX 02L1303011

    Patients

    Seq Age Sex Outcome Treatment
    1