BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 764226 · Received July 25, 2006

    Report

    Report Number
    1423500-2006-00859
    Event Type
    Malfunction
    Date Received
    July 25, 2006
    Date of Event
    June 26, 2006
    Report Date
    June 26, 2006
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    BAXTER PRODUCT SURVEILLANCE RECEIVED A REPORT THAT A TRANSFER SET HAD BROKEN OCCLUDER FEET. THE TRANSFER SET HAD BEEN IN PLACE FOR 3 MONTHS. THE PT HAD BEEN ON PERITONEAL DIALYSIS SINCE 03/24/2003. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS INCIDENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN DIANEAL PD2 SOLUTION (STRENGTH UNK)