BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON SILENT HUMIDIFIER ADAPTOR 011

    MDR report key: 3843666 · Received March 25, 2014

    Report

    Report Number
    1417411-2014-00014
    Event Type
    Malfunction
    Date Received
    March 25, 2014
    Date of Event
    January 24, 2014
    Report Date
    March 4, 2014
    Manufacturer
    TELEFELX MEDICAL
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 REVIEW OF MFG EVENT LOG: SHOWS NO ISSUES THAT MAY HAVE CONTRIBUTED TO ANY QUALITY ISSUES REPORTED. ALL PROCESS PARAMETERS WERE WITHIN SPECIFICATION. ALL IN-PROCESS QA INSPECTIONS WERE ACCEPTABLE. POST STERILITY AND PACKAGE INTEGRITY TESTS SHOWS ONE NON-CONFORMANCE THAT MAY HAVE AN IMPACT ON THE QUALITY ISSUE REPORTED. NON-CONFIRMING MATERIAL WAS SORTED FOR A DEFECT, RE-INSPECTED, AND FOUND TO BE ACCEPTABLE PER INTERNAL SPECIFICATION. NO SAMPLE AVAILABLE FROM THE CUSTOMER TO INVESTIGATE. TELEFLEX WILL CONTINUE TO MONITOR FEEDBACK FROM THE CUSTOMERS ON ISSUES RELATED TO PIN HOLE ON PACKAGE FOUND AT INSPECTION ON ADAPTOR PRODUCTS. NO SAMPLE AVAILABLE FROM THE CUSTOMER TO INVESTIGATE. COMPLAINT NOT CONFIRMED. ROOT CAUSE UNK.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: A PIN HOLE WAS DETECTED ON THE PACKAGE. THE ALLEGED ISSUE WAS DETECTED BY THE DISTRIBUTOR (IMJ) DURING INCOMING INSPECTION. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174041 HUDSON SILENT HUMIDIFIER ADAPTOR 011 HUMIDIFIER ADAPTOR BTT TELEFELX MEDICAL F01311

    Patients

    Seq Age Sex Outcome Treatment
    1