BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON SILENT HUMIDIFIER ADAPTOR

    MDR report key: 3131253 · Received May 23, 2013

    Report

    Report Number
    1417411-2013-00013
    Event Type
    Malfunction
    Date Received
    May 23, 2013
    Date of Event
    April 4, 2013
    Report Date
    May 8, 2013
    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, DIMENSIONAL AND FUNCTIONAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RETURNED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED. THE REVIEW SHOWED 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. TELEFLEX WILL CONTINUE TO MONITOR FEEDBACK FROM THE CUSTOMERS ON ISSUES RELATED TO PIN HOLE(S) FOUND AT INSPECTION ON ADAPTOR PRODUCTS. NO SAMPLE AVAILABLE FROM THE CUSTOMER TO INVESTIGATE. COMPLAINT NOT CONFIRMED. ROOT CAUSE IS UNK.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: DURING INCOMING INSPECTION THE REPORT INDICATES A PIN HOLE IN THE PACKAGE. NO REPORT OF PT INVOLVEMENT/INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229248 HUDSON SILENT HUMIDIFIER ADAPTOR HUMIDIFIER ADAPTOR BTT TELEFELX MEDICAL D01211

    Patients

    Seq Age Sex Outcome Treatment
    1