BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERLINK CATHETER EXTENSION SET/MALE LUER

    MDR report key: 1024011 · Received April 5, 2008

    Report

    Report Number
    6000001-2007-04206
    Event Type
    Malfunction
    Date Received
    April 5, 2008
    Date of Event
    January 23, 2007
    Report Date
    January 26, 2007
    Manufacturer
    AIBONITO
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE, SHOULD THE REPORTED DEVICE BE RETURNED AND EVALUATED A FOLLOW UP REPORT WILL BE SUBMITTED. THE CODE REPORTED BY INTERNATIONAL AFFILIATE WAS LISTED AS A2N3371, LOT S06G18175R OR S06G21088R. THIS CODE IS MANUFACTURED IN SINGAPORE AND IS ONLY DISTRIBUTED IN JAPAN. THE MEDWATCH WAS FILED FOR THE US CODE, 2N3371, WHICH IS THE SAME AS OR SIMILAR.

    Description of Event or Problem · 1

    INTERNATIONAL COMPLAINT RECEIVED FROM JAPAN NCC. CUSTOMER REPORTS DURING PATIENT USE WITH LIDOCAINE, MORPHINE, HYDROCHLORIDE AND KETAMINE THE MALE CONNECTOR SEPARATED. BLOOD BACK OCCURRED BUT NO TREATMENT REQUIRED AND NO INJURY. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERLINK CATHETER EXTENSION SET/MALE LUER INTERLINK EXTENSION SETS FPA AIBONITO NA NA01

    Patients

    Seq Age Sex Outcome Treatment
    1