BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON NEONATE DUAL HEATED DUAL DRAIN

    MDR report key: 3970595 · Received June 2, 2014

    Report

    Report Number
    3004365956-2014-00206
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 16, 2014
    Manufacturer
    TELEFLEX
    Product Code
    CAG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 DETERMINE THE SOURCE OF DEFECT REPORTED. THIS CUSTOMER COMPLAINT CAN NOT 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 THE COLUMN DID NOT WORK AFTER SET-UP. THE ALLEGED FAILURE OCCURRED PRIOR TO PATIENT USE DURING PRE-TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320900 HUDSON NEONATE DUAL HEATED DUAL DRAIN BREATHING CIRCUIT CAG TELEFLEX

    Patients

    Seq Age Sex Outcome Treatment
    1