BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON VENTILATOR TUBING SET, LONG LENGTH

    MDR report key: 3543304 · Received November 7, 2013

    Report

    Report Number
    3004365956-2013-00364
    Event Type
    Malfunction
    Date Received
    November 7, 2013
    Date of Event
    October 28, 2013
    Report Date
    October 28, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TWO PICTURES OF THE UNIT OF CATALOG NUMBER 1607 (VENTILATOR TUBING SET, LONG LENGTH) WERE RECEIVED FOR ANALYSIS. THEY WERE VISUALLY INSPECTED AND THE FAULT REPORTED BY THE CUSTOMER CANNOT BE DETECTED IN THE PROVIDED PICTURES, IT CAN ONLY BE IDENTIFIED THE COMPONENTS P/N 30536 (CLOSURE, SINGLE) AND P/N 12138-02 (WYE, 15 DEGREE ADULT, 22MM, W/ONE PORT) RELATED WITH THE COMPLAINT, BUT NOT THE FAILURE MODE. A DIMENSIONAL AND FUNCTIONAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RETURNED. THE DEVICE HISTORY RECORD (DHR) OF BATCH NUMBER 02G1302131 HAS BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND 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. THE ASSEMBLY PROCESS AND MANUFACTURING PROCEDURE OF CATALOG NUMBER 1607 WERE REVIEWED AND NO FINDINGS RELATED TO THE REPORTED ISSUE WERE FOUND. THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED BASED ONLY ON THE INFORMATION PROVIDED, IN ORDER TO PERFORM A PROPER INVESTIGATION IT IS NECESSARY TO EVALUATE THE SAMPLE INVOLVED ON THE INCIDENT. HOWEVER, EXTERNAL AND INTERNAL DIAMETERS OF PRODUCTS P/N 30536 (CLOSURE, SINGLE) AND P/N 12138-02 (WYE, 15 DEGREE ADULT, 22MM, W/ONE PORT) WERE VERIFIED IN THE CURRENT INVENTORY AND THEY WERE FOUND WITHIN SPECIFICATION. IF DEFECTIVE SAMPLE BECOMES AVAILABLE AT A LATER DATE THIS COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THAT THE AIRWAY PRESSURE AND TEMPERATURE MONITORING PORT CAP IS LOOSE AND HAS POPPED OFF THE "Y" CONNECTOR DURING USE. THE PORT AND /OR CIRCUIT WAS REPLACED. NO REPORT OF A PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576712 HUDSON VENTILATOR TUBING SET, LONG LENGTH VENTILATOR TUBING BZO TELEFLEX MEDICAL 02G1302131

    Patients

    Seq Age Sex Outcome Treatment
    1 VENTILATOR