BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON SILENT HUMIDIFIER ADAPTOR

    MDR report key: 3131252 · Received May 23, 2013

    Report

    Report Number
    1417411-2013-00015
    Event Type
    Malfunction
    Date Received
    May 23, 2013
    Date of Event
    April 4, 2013
    Report Date
    May 8, 2013
    Manufacturer
    TELEFLEX 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 INSPECTION WAS CONDUCTED FROM A PHOTO, PROVIDED BY THE CUSTOMER, OF THE DEFECTIVE SAMPLE OF THE PRODUCT INVOLVED IN THE COMPLAINT. THE PHOTO SHOWS A CLOSE-UP VIEW OF THE BOTTOM PART OF THE ADAPTOR'S PACKAGE WITH MISSING LOT NUMBER DESIGNATION FOR THIS PRODUCT. HOWEVER, BASED ON THE PHOTO, THE COMPLAINT INVESTIGATOR CANNOT DISCERN IF THERE'S AN IMPRINT OF THE LOT NUMBER CHARACTERS OR NOT. THE IMPRINT WOULD INDICATE OUT OF RIBBON CONDITION. IF THERE IS NO IMPRINT A SENSOR THAT TRIGGERS PRINTING MALFUNCTIONED. NO OTHER ISSUES WERE NOTED. A 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. THIS IS AN ISOLATED INCIDENT. TELEFLEX WILL CONTINUE TO MONITOR FEEDBACK FROM THE CUSTOMERS ON ISSUES RELATED TO A PACKAGE INDICATION ERROR (NO LOT NUMBER) FOUND AT INSPECTION ON ADAPTOR PRODUCTS. THE SAMPLE IS NEEDED TO EVALUATE FOR A ROOT CAUSE.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: DURING INCOMING INSPECTION, THE REPORT INDICATES A PACKAGE INDICATION ERROR (NO LOT NUMBER). NO REPORT OF PT INVOLVEMENT/INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228679 HUDSON SILENT HUMIDIFIER ADAPTOR HUMIDIFIER ADAPTOR BTT TELEFLEX MEDICAL M06111

    Patients

    Seq Age Sex Outcome Treatment
    1