BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON CORR-A-FLEX TUBING

    MDR report key: 2864512 · Received December 6, 2012

    Report

    Report Number
    3004365956-2012-00341
    Event Type
    Malfunction
    Date Received
    December 6, 2012
    Date of Event
    August 8, 2012
    Report Date
    November 22, 2012
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION AT THE TIME OF THIS REPORT. SOME IMAGES OF CATALOG NUMBER 1680 WERE RECEIVED FOR ANALYSIS. FROM THESE IMAGES A FOREIGN SUBSTANCE WAS FOUND AND THIS CONFIRMS THE COMPLAINT DESCRIPTION. THE DEVICE HISTORY RECORD (DHR) FOR THE REPORTED LOT NUMBER WAS CONDUCTED. NO ISSUES OR DISCREPANCIES WERE FOUND WHICH COULD POTENTIALLY RELATE TO THIS COMPLAINT. THE DHR SHOWS THAT THE PRODUCT WAS ASSEMBLED AND INSPECTED ACCORDING TO SPECIFICATIONS. THE PICTURES PROVIDED FOR EVALUATION CONFIRM THE DEFECT. THE FOREIGN SUBSTANCE REPORTED BY THE CUSTOMER IS A PIECE OF PLASTIC FROM THE SAME RESIN USED TO EXTRUDE THE TUBE. AN INVESTIGATION WAS PERFORMED ON THE EXTRUSION PRODUCTION LINE AND THE FREQUENCY OF THE DIE'S CLEANING OF THE EXTRUSION MACHINES. A CORRECTIVE ACTION WAS IMPLEMENTED TO HELP ELIMINATE THE DEGRADED RESIN THAT ACCUMULATES ON THE DIE END THAT CAUSES THE ISSUE SHOWN ON THE PHOTO PROVIDED BY THE CUSTOMER.

    Description of Event or Problem · 1

    THE COMPLAINT WAS REPORTED AS: A FOREIGN SUBSTANCE WAS FOUND INSIDE OF THE TUBING. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON CORR-A-FLEX TUBING CORRUGATED TUBING BZO TELEFLEX MEDICAL 02M1100561

    Patients

    Seq Age Sex Outcome Treatment
    1