BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON SILENT HUMIDIFIER ADAPTOR

    MDR report key: 2864448 · Received December 6, 2012

    Report

    Report Number
    1417411-2012-00044
    Event Type
    Malfunction
    Date Received
    December 6, 2012
    Date of Event
    November 12, 2012
    Report Date
    November 26, 2012
    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

    THE DEVICE SAMPLE WAS NOT RETURNED FOR EVALUATION AT THE TIME OF THIS REPORT. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED. THE DHR 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. AT THE TIME OF THIS REPORT THE SAMPLE WAS NOT AVAILABLE FROM THE CUSTOMER TO INVESTIGATE. THE COMPLAINT CAN NOT BE CONFIRMED AND A ROOT CAUSE DETERMINED. TELEFLEX WILL CONTINUE TO MONITOR FEEDBACK FROM CUSTOMERS ON ISSUES RELATED TO PINHOLES FOUND AT INSPECTION ON ADAPTOR PRODUCTS.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: DURING INCOMING INSPECTION A PINHOLE IN THE PACKAKGE WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON SILENT HUMIDIFIER ADAPTOR HUMIDIFIER ADAPTOR BTT TELEFELX MEDICAL A05211

    Patients

    Seq Age Sex Outcome Treatment
    1