BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH FLOW HEATED INSUFFLATOR TUBING (5BX)

    MDR report key: 2760390 · Received September 18, 2012

    Report

    Report Number
    2648666-2012-00307
    Event Type
    Malfunction
    Date Received
    September 18, 2012
    Date of Event
    September 7, 2012
    Report Date
    September 7, 2012
    Manufacturer
    STRYKER ENDOSCOPY PUERTO RICO
    Product Code
    NKC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE TUBESET WAS OPENED, A FOREIGN PARTICLE WAS NOTICED ON THE INSIDE OF THE STERILE PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIGH FLOW HEATED INSUFFLATOR TUBING (5BX) INSUFFLATOR TUBING NKC STRYKER ENDOSCOPY PUERTO RICO 12187FE2

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK