BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON CORR-A-FLEX TUBING

    MDR report key: 2833868 · Received November 5, 2012

    Report

    Report Number
    3004365956-2012-00310
    Event Type
    Malfunction
    Date Received
    November 5, 2012
    Date of Event
    August 27, 2012
    Report Date
    October 19, 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 SAMPLE WAS NOT RETURNED FOR EVALUATION. THE PICTURES PROVIDED FOR EVALUATION CONFIRM THE DEFECT REPORTED BY THE CUSTOMER. THE FOREIGN SUBSTANCES IS A PIECE OF PLASTIC FROM THE SAME RESIN SUED TO EXTRUDE THE TUBE. A CORRECTIVE ACTION WAS IMPLANTED TO AIDE IN THE ELIMINATION OF THE DEGRADED RESIN THAT ACCUMULATED ON THE INJECTION DIE.

    Description of Event or Problem · 1

    THE COMPLAINT WAS REPORTED AS: A FOREIGN SUBSTANCE WAS FOUND IN THE INNER WALL OF THE CORRUGATED TUBE. THE REPORTED DEFECT WAS DISCOVERED PRIOR TO PT USE. NO PT INJURY REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1