BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEROYAL INSUFFLATION TUBING

    MDR report key: 2822015 · Received October 3, 2012

    Report

    Report Number
    3004605321-2012-00016
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Date of Event
    November 13, 2008
    Report Date
    October 3, 2012
    Manufacturer
    DEROYAL INTERCONTINENTAL
    Product Code
    NKC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER STATES INSUFFLATION TUBING WILL NOT ALLOW CO2 TO FLOW THROUGH. SURGERY WAS DELAYED WHILE REPLACEMENT TUBING WAS LOCATED. THIS INCIDENT OCCURRED SEVERAL TIMES.

    Description of Event or Problem · 1

    CUSTOMER STATES INSUFFLATION TUBING WILL NOT ALLOW CO2 TO FLOW THROUGH. SURGERY WAS DELAYED WHILE REPLACEMENT TUBING WAS LOCATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEROYAL INSUFFLATION TUBING PRODUCT CODE - HIF, INSUFFLATION TUBING NKC DEROYAL INTERCONTINENTAL TUBING W/ 0.1UM FIL 161221771

    Patients

    Seq Age Sex Outcome Treatment
    1