BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON ADULT ANESTHESIA CIRCUIT, 40"

    MDR report key: 3181893 · Received June 17, 2013

    Report

    Report Number
    3004365956-2013-00200
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    April 19, 2013
    Report Date
    May 24, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BSJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL LOT NUMBERS ARE UNK. THE SUSPECT LOT NUMBERS ARE REPORTED AS: 02D1102812, 02E1001965, 02H1002326, 02J1002682 AND 02L1100768. A VISUAL, DIMENSIONAL AND FUNCTIONAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RETURNED. THE DEVICE HISTORY RECORDS OF BATCH NUMBERS 02D1102812, 02E1001965, 02H1002326, 02J1002682 AND 02L1100768 HAVE BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND RELATED TO THIS COMPLAINT. NO NONCONFORMANCE REPORTS WERE ORIGINATED FOR THE LOT IN QUESTION THAT CAN BE ASSOCIATED TO THE COMPLAINT REPORTED. DHR SHOWS THAT THE PRODUCT WAS ASSEMBLED AND INSPECTED ACCORDING TO OUR SPECIFICATIONS. CUSTOMER COMPLAINT CANNOT BE CONFIRMED SINCE THE DEFECTIVE SAMPLE OR A PICTURE OF IT ARE UNAVAILABLE TO PERFORM A PROPER INVESTIGATION AND DETERMINE THE ROOT CAUSE. HOWEVER BASED ON A SIMILAR COMPLAINT THE ROOT CAUSE COULD BE RELATED TO THE MOLDING PROCESS OF THE FITTING ADAPTOR (P/N (B)(4)), 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. CURRENTLY, THIS PRODUCT CODE IS RUNNING ON THE NL003 WHICH IS THE MACHINE THAT IS VALIDATED UNDER THE DECOUPLE METHOD. THE ACTUAL INVENTORY OF THE FITTING ADAPTORS BELONGS TO THIS MACHINE AND WAS INSPECTED BY THE DEFECT.

    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 PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274097 HUDSON ADULT ANESTHESIA CIRCUIT, 40" ANESTHESIA CIRCUIT BSJ TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1