BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PILLING CLJ INNER TUBE #5 W TUCKER VAL

    MDR report key: 2561698 · Received April 30, 2012

    Report

    Report Number
    1044475-2012-00040
    Event Type
    Malfunction
    Date Received
    April 30, 2012
    Date of Event
    March 28, 2012
    Report Date
    April 5, 2012
    Manufacturer
    TELEFLEX
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS NOT RECEIVED BY THE MANUFACTURER AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: "CUSTOMER ALLEGES FLAP FROM VALVE BROKE WHILE IN USE. IT DID NOT COME OFF COMPLETELY BECAUSE IT WAS STILL ON THE VALVE BY ONE HINGE." NO PATIENT INJURY REPORTED. PATIENT CURRENT CONDITION IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PILLING CLJ INNER TUBE #5 W TUCKER VAL INNER TUBE BTR TELEFLEX MM9

    Patients

    Seq Age Sex Outcome Treatment
    1