BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON SILENT HUMIDIFIER ADAPTOR

    MDR report key: 3788708 · Received January 21, 2014

    Report

    Report Number
    1417411-2014-00003
    Event Type
    Malfunction
    Date Received
    January 21, 2014
    Date of Event
    December 5, 2013
    Report Date
    January 7, 2014
    Manufacturer
    TELEFELX MEDICAL
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL, DIMENSIONAL AND FUNCTIONAL INSPECTION COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DHR (DEVICE HISTORY RECORD) CONCLUDED: REVIEW OF MANUFACTURED 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. ALL POST STERILITY AND PACKAGE INTEGRITY TESTS WERE ACCEPTABLE. NO SAMPLE RETURNED FROM THE CUSTOMER TO INVESTIGATE. COMPLAINT NOT CONFIRMED. ROOT CAUSE - UNKNOWN. TELEFLEX WILL CONTINUE TO MONITOR FEEDBACK FROM THE CUSTOMERS ON ISSUES RELATED TO PINHOLE ON THE PACKAGE FOUND AT INSPECTION ON ADAPTOR PRODUCTS.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: DURING INCOMING INSPECTION, BY THE DISTRIBUTOR (IMJ), A PINHOLE WAS DETECTED ON PACKAGE. THE DISTRIBUTOR (IMJ - (B)(4) DISTRIBUTOR) REPORTS A TOTAL OF (10) TEN PACKAGES WITH ALLEGED DEFECT OF "PINHOLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50916 HUDSON SILENT HUMIDIFIER ADAPTOR HUMIDIFIER ADAPTOR BTT TELEFELX MEDICAL J01211

    Patients

    Seq Age Sex Outcome Treatment
    1