BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP PD TRANSFER SET (EASY-LOCK) WITH TWIST CLAMP

    MDR report key: 1230754 · Received November 17, 2008

    Report

    Report Number
    1423500-2007-00067
    Event Type
    Malfunction
    Date Received
    November 17, 2008
    Date of Event
    December 6, 2006
    Report Date
    December 7, 2006
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    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 ON FEB 08 2007.

    Description of Event or Problem · 1

    BAXTER PRODUCT SURVEILLANCE RECEIVED NOTIFICATION OF AN INCIDENT FROM THE INTERNATIONAL AFFILIATE WHERE BAXTER REPORTED LEAKAGE AROUND A TWIST CLAMP AFTER 120 DAYS OF USE. THE SAMPLE IS AVAILABLE AND HAS BEEN REQUESTED. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS ASSOCIATED WITH THIS INCIDENT PER THE INTERNATIONAL AFFILIATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP PD TRANSFER SET (EASY-LOCK) WITH TWIST CLAMP MINICAP TRANSFER SETS KDJ BAXTER HEALTHCARE CORPORATION NA NA01

    Patients

    Seq Age Sex Outcome Treatment
    1