BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATH TEMPO 4

    MDR report key: 1030567 · Received April 14, 2008

    Report

    Report Number
    9616099-2008-00983
    Event Type
    Malfunction
    Date Received
    April 14, 2008
    Date of Event
    February 25, 2008
    Report Date
    March 18, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQO
    PMA / PMN Number
    K973401
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THE PRODUCT IS NOT AVAILABLE FOR EVAL. THIS IS ONE OF NINE PRODUCTS INVOLVED IN THE SAME EVENT AND REPORTED UNDER MANUFACTURING NUMBERS: 9616099-2008-00978, 9616099-2008-00981, 9616099-2008-00984, 9616099-2008-00985, 9616099-2008-00986, 9616099-2008-00987, 9616099-2008-00988 AND 9616099-2008-00989.

    Description of Event or Problem · 1

    THE REPORT RECEIVED INDICATED THAT DURING A VISUAL EXAMINATION OF THE PRODUCT, THE CUSTOMER IDENTIFIED THE PRESENCE OF STRANDS AND PARTICLES. FURTHER INFO INDICATED THE PROBLEM WAS VISIBLE THROUGH THE STERILE POUCH, AS SUCH THE DEVICES WERE NOT REMOVED FROM THE STERILE POUCH. THERE WERE NO ANOMALIES NOTED WITH THE PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATH TEMPO 4 DIAGNOSTIC ENDOVASCULAR CATHETERS (DQO) DQO CORDIS DE MEXICO NA 13239087

    Patients

    Seq Age Sex Outcome Treatment
    1 NA