BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON ADULT ANESTHESIA BREATHING CIRCUIT

    MDR report key: 3190584 · Received June 21, 2013

    Report

    Report Number
    3004365956-2013-00197
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 30, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BYX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL INSPECTION WAS CONDUCTED ON THE PICTURES RECEIVED. THE VISUAL INSPECTION FOUND THE COMPONENT P/N 10503 CRACKED. 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 ON THE REPORTED LOT NUMBER (02B1200674). THE DHR REVIEW SHOWED NO ISSUES OR DISCREPANCIES RELATED TO THE COMPLAINT. THE DHR SHOWED THAT THE PRODUCT WAS ASSEMBLED AND INSPECTED ACCORDING TO OUR SPECIFICATIONS. NO NON-CONFORMANCE REPORTS WERE ORIGINATED FOR THE DEVICE WHICH COULD BE ASSOCIATED TO THE COMPLAINT REPORTED. THE CUSTOMER COMPLAINT WAS CONFIRMED BASED ON REVIEW OF THE PICTURES RECEIVED. THE ROOT CAUSE COULD BE RELATED TO THE MOLDING PROCESS OF THE FITTING ADAPTOR (P/N 10503), A SLOW INJECTION PROCESS OF THE RESIN INTO THE MOLD COULD CAUSE THAT THE WELD LINE WAS NOT STRONG ENOUGH, CAUSING A CRACK WHEN THE FITTING ADAPTOR WAS STRESSED. A CORRECTIVE ACTION WAS IMPLEMENTED TO ADDRESS THIS ISSUE. THE REPORTED LOT NUMBER FOR THIS COMPLAINT WAS MANUFACTURED BEFORE THE CORRECTIVE ACTION.

    Description of Event or Problem · 1

    THE COMPLAINT WAS REPORTED AS: THE CUSTOMER ALLEGES THAT THE CONNECTORS OF THE ANESTHESIA BAGS FOR THE ANESTHESIA CIRCUIT SYSTEM WERE FOUND CRACKED. NO REPORT OF PT INJURY/INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282563 HUDSON ADULT ANESTHESIA BREATHING CIRCUIT ANESTHESIA BREATHING CIRCUIT BYX TELEFLEX MEDICAL 02B1200674

    Patients

    Seq Age Sex Outcome Treatment
    1