BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELEFLEX ISIS SUCTION ACCESSORY PACK

    MDR report key: 3833120 · Received March 24, 2014

    Report

    Report Number
    8040412-2014-00065
    Event Type
    Malfunction
    Date Received
    March 24, 2014
    Date of Event
    January 23, 2014
    Report Date
    March 10, 2014
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNK IF THE DEVICE SAMPLE IS AVAILABLE FOR EVAL.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THAT THE SUCTION PORT ON THE ISIS ENDOTRACHEAL TUBE DETACHED DURING TESTING. THE CUSTOMER CONDUCTED A TEST IN THEIR WAREHOUSE (DUE TO ISSUES DURING USES). THE TESTING OF THE DEVICES IN THE WAREHOUSE TOTALED (B)(4) DEVICES. A TOTAL OF (B)(4) LOT NUMBERS WERE TESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172507 TELEFLEX ISIS SUCTION ACCESSORY PACK ET ACCESSORY PACK BTR TELEFLEX MEDICAL 10DE15

    Patients

    Seq Age Sex Outcome Treatment
    1