BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KII BALLOON BLUNT TIP SYSTEM

    MDR report key: 5982965 · Received September 28, 2016

    Report

    Report Number
    5982965
    Event Type
    Malfunction
    Date Received
    September 28, 2016
    Date of Event
    July 11, 2016
    Report Date
    August 29, 2016
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS OPENED FOR USE. A STAIN WAS NOTED ON THE SYRINGE PORTION OF THE SYSTEM. THE DEVICE WAS REMOVED FROM USE IMMEDIATELY. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636190 KII BALLOON BLUNT TIP SYSTEM LAPAROSCOPE, GENERAL, PLASTIC GCJ APPLIED MEDICAL 1269410

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR