BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNO NIKO-FIX (100/1000) STER IN

    MDR report key: 4317427 · Received November 20, 2014

    Report

    Report Number
    3007966929-2014-00100
    Event Type
    Malfunction
    Date Received
    November 20, 2014
    Date of Event
    June 1, 2014
    Report Date
    October 23, 2014
    Manufacturer
    UNOMEDICAL LTD.
    Product Code
    KMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. THERE WERE NO REPORTS OF THE PATIENT BEING HARMED AS A RESULT OF THIS MALFUNCTION. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS COMPLAINT INVOLVES EIGHT DIFFERENT LOTS; THEREFORE ADDITIONAL RECORDS HAVE BEEN CREATED IN ORDER TO CAPTURE THIS INFORMATION AND SEPARATE FDA FORM 3500A'S HAS BEEN GENERATED TO ADDRESS THE OTHER CASES. REPORTED TO FDA ON NOVEMBER 20, 2014.

    Description of Event or Problem · 1

    IT IS REPORTED THAT PRODUCT BATCHES WERE SHIPPED DIRECTLY TO THE DISTRIBUTION CENTRE AND SHIPPED TO CUSTOMERS BUT HAVE NO RECORD OF THE STERILIZATION CERTIFICATION. ADDITIONAL INFORMATION WAS RECEIVED ON 10/31/2014 AND REPORTED IT IS UNDETERMINED IF ANY PRODUCT AHS BEEN USED OR IS IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755202 UNO NIKO-FIX (100/1000) STER IN INTRAVASCULAR CATHETER SECUREMENT KMK UNOMEDICAL LTD. 417118 171653

    Patients

    Seq Age Sex Outcome Treatment
    1