BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON CIRCUIT, PEDIATRIC, DUAL LIMB

    MDR report key: 3972832 · Received April 28, 2014

    Report

    Report Number
    3004365956-2014-00170
    Event Type
    Malfunction
    Date Received
    April 28, 2014
    Date of Event
    April 2, 2014
    Report Date
    April 7, 2014
    Manufacturer
    TELEFLEX
    Product Code
    CAG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. A DHR (DEVICE HISTORY RECORD) REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER WAS NOT PROVIDED. NO CORRECTIVE ACTION CAN BE ESTABLISHED SINCE THE SAMPLE IS NOT AVAILABLE TO PERFORM AN INVESTIGATION AND DETERMINED THE SOURCE OF DEFECT REPORTED. THIS CUSTOMER COMPLAINT CANNOT BE CONFIRMED DUE TO THE LACK OF PRODUCT SAMPLE TO PERFORM AN INVESTIGATION AND DETERMINE THE SOURCE OF DEFECT REPORTED. IF DEFECTIVE SAMPLE BECOMES AVAILABLE AT A LATER DATE THIS COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THAT A TEAR DEVELOPED IN THE CIRCUIT. NO PT INJURY OR CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253718 HUDSON CIRCUIT, PEDIATRIC, DUAL LIMB BREATHING CIRCUIT CAG TELEFLEX

    Patients

    Seq Age Sex Outcome Treatment
    1