BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON CIRCUIT, NEONATAL, DUAL HTD LIMB W/DUAL W

    MDR report key: 4563715 · Received February 26, 2015

    Report

    Report Number
    3004365956-2015-00074
    Event Type
    Malfunction
    Date Received
    February 26, 2015
    Date of Event
    January 29, 2015
    Report Date
    February 2, 2015
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 RETURNED. THE DEVICE HISTORY RECORD OF BATCH NUMBER 74L1402115 THAT BELONG TO CATALOG NUMBER 780-15 HAS BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND WHICH COULD POTENTIALLY RELATE TO THIS COMPLAINT. NO NON CONFORMANCE REPORTS WERE ORIGINATED FOR THE LOT IN QUESTION THAT CAN BE ASSOCIATED TO THE COMPLAINT REPORTED. THE DHR SHOWS THAT THE PRODUCT WAS ASSEMBLED AND INSPECTED ACCORDING TO OUR SPECIFICATIONS. NO CORRECTIVE ACTION CAN BE ESTABLISHED SINCE THE SAMPLE IS NOT AVAILABLE TO PERFORM AN INVESTIGATION AND DETERMINE THE SOURCE OF DEFECT REPORTED. CUSTOMER COMPLAINT CANNOT BE CONFIRMED BASED ONLY ON THE INFO PROVIDED, TO PERFORM AN INVESTIGATION AND DETERMINE THE SOURCE OF DEFECT REPORTED, IT IS NECESSARY TO EVALUATE THE SAMPLE INVOLVED ON THIS COMPLAINT. AN ATTEMPT TO DUPLICATE THE FAILURE MODE WAS MADE BUT AT THE TIME THERE WAS NO INVENTORY OF THE INVOLVED PRODUCT CODE AVAILABLE AT THE FACILITY AND IT WAS NOT BEING MFG AT THE TIME. IF 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 CIRCUIT DID NOT PASS THE LEAK TEST. NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137441 HUDSON CIRCUIT, NEONATAL, DUAL HTD LIMB W/DUAL W BREATHING CIRCUIT CAG TELEFLEX MEDICAL 74L1402115

    Patients

    Seq Age Sex Outcome Treatment
    1