BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON ADAPTOR,040 HUM,INTL

    MDR report key: 5103841 · Received September 25, 2015

    Report

    Report Number
    1417411-2015-00151
    Event Type
    Malfunction
    Date Received
    September 25, 2015
    Date of Event
    September 1, 2015
    Report Date
    September 16, 2015
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RECEIVED AT OUR FACILITY. THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES RELATED TO FUNCTIONAL ISSUES ON THE MOLDED COMPONENT INVOLVED IN THIS COMPLAINT DURING THE MANUFACTURE OF THE MATERIAL. REGARDING THIS ISSUE A CAPA FILE (B)(4) WAS OPENED. ACCORDING TO THE CAPA INVESTIGATION SO FAR THE ROOT CAUSE FOR THE ISSUE WAS THE POSITIONING OF THE THREAD LEAD AND THE SOFTNESS OF THE NEW RESIN USED FOR THE SNAP ADAPTOR. CUSTOMER COMPLAINT CANNOT BE CONFIRMED, BASED ONLY ON THE INFORMATION PROVIDED, TO PERFORM A CORRECT INVESTIGATION AND DETERMINE THE SOURCE OF DEFECT REPORTED IT IS NECESSARY TO EVALUATE THE SAMPLE INVOLVED IN THIS COMPLAINT. AN ATTEMPT TO DUPLICATE THE FAILURE MODE WAS MADE, BUT AT THE TIME THERE IS NO INVENTORY OF THE INVOLVED PRODUCT CODE (400040; ADAPTOR ,040 HUM,INTL) AVAILABLE AT THE FACILITY NOR IS BEING MANUFACTURED AT THE TIME; HOWEVER REGARDING OTHER CUSTOMER COMPLAINTS FOR THIS SAME ISSUE, A CAPA FILE (B)(4) WAS OPENED TO PERFORM A FURTHER INVESTIGATION. IF THE DEVICE SAMPLE BECOMES AVAILABLE AT A LATER DATE THIS COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT THE ADAPTOR DOES NOT FIT PROPERLY TO THE FLOW METER. THE ADAPTOR BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636186 HUDSON ADAPTOR,040 HUM,INTL ADAPTOR BTT TELEFLEX MEDICAL 03D15

    Patients

    Seq Age Sex Outcome Treatment
    1