BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON CIRCUIT, PEDIATRIC, SINGLE HTD LIMB W/WAT

    MDR report key: 3910089 · Received February 25, 2014

    Report

    Report Number
    3004365956-2014-00075
    Event Type
    Malfunction
    Date Received
    February 25, 2014
    Date of Event
    January 7, 2014
    Report Date
    February 2, 2014
    Manufacturer
    TELEFLEX
    Product Code
    CAG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REC'D BY THE MANUFACTURER, BUT THE INVESTIGATION IS INCOMPLETE AT THE TIME OF THIS REPORT. TWO PICTURES OF A SECTION OF THE PRODUCT CATALOG NUMBER 780-23 (CIRCUIT, PEDIATRIC, SINGLE HTD LIMB W/WATE) WERE REC'D FOR ANALYSIS. THEY WERE VISUALLY INSPECTED FOUNDING CRACKS ON SECTIONS OF THE CORRUGATED TUBING. NO OTHER ISSUES WERE FOUND. THE DEVICE HISTORY RECORD (DHR) OF BATCH NUMBER (B)(4) HAS BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND RELATED TO THIS COMPLAINT. NO NON CONFORMANCE 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.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THAT THEY FOUND A FEW CRACKS IN THE CORRUGATED TUBE OF THE CIRCUIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116228 HUDSON CIRCUIT, PEDIATRIC, SINGLE HTD LIMB W/WAT BREATHING CIRCUIT CAG TELEFLEX 02G1201687

    Patients

    Seq Age Sex Outcome Treatment
    1