BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECH MEDICAL INSUFFLATION TUBING SET

    MDR report key: 3181499 · Received June 12, 2013

    Report

    Report Number
    3181499
    Event Type
    Malfunction
    Date Received
    June 12, 2013
    Date of Event
    May 24, 2013
    Report Date
    June 12, 2013
    Manufacturer
    PROGRESSIVE MEDICAL
    Product Code
    NKC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    THE NURSE WHO WAS OPERATING THE MACHINE NOTICED THERE WAS A LEAK IN THE TUBING THAT CONNECTED TO THE INSUFFLATION MACHINE. THE TUBING WAS REPLACED AND THE SURGERY CONTINUED WITHOUT AN ISSUE. AT ANOTHER TIME FOLLOWING THIS EVENT TUBING FROM THE SAME LOT # BOX HAD THE SAME ISSUE; LEAK IN TUBING. THE BOX WAS REMOVED AND OUR HOSPITAL WILL REPORT THE ISSUE TO THE COMPANY AS WELL AS LOOK TO GET PRODUCT REPLACED.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?LAPAROSCOPIC CHOLECYSTECTOMY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265452 TECH MEDICAL INSUFFLATION TUBING SET TUBING/TUBING WITH FILTER, INSUFFLATION, LAPAROSCOPIC NKC PROGRESSIVE MEDICAL * 8411205145

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR NO OTHER THERAPIES