BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERLINK CATHETER EXTENSION SET/MALE LUER

    MDR report key: 1024012 · Received April 5, 2008

    Report

    Report Number
    6000001-2000-04201
    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

    THIS REPORT IS BEING RESUBMITTED IN ACCORDANCE WITH INSTRUCTIONS FROM FDA TO ADDRESS A MANUFACTURER REPORT SEQUENCE NUMBER ISSUE THAT OCCURRED WHEN THIS MDR OR SUPPLEMENT WAS ORIGINALLY SUBMITTED TO THE FDA FEB 07 2007. 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 BAXTER WAS LISTED AS LOT S06G18175R OR S06G21088R.

    Description of Event or Problem · 1

    INTERNATIONAL COMPLAINT RECEIVED. CUSTOMER REPORTS DURING PATIENT USE WITH LIDOCAINE, MORPHINE AND HYDROCHLORIDE MALE CONNECTOR SEPARATED. BLOOD BACK OCCURRED BUT NO TREATMENT REQUIRED AND NO INJURY. NO OTHER ADDITONAL INFORMATION WAS 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