BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 730583 · Received June 16, 2006

    Report

    Report Number
    1423500-2006-00694
    Event Type
    Malfunction
    Date Received
    June 16, 2006
    Date of Event
    May 6, 2006
    Report Date
    May 19, 2006
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    BAXTER EL SALVADOR REPORTS THAT A NURSE FROM "HOSP ROSALES" REPORTED THAT A PT "EJB", 61 YRS OLD, NEEDED TO REPLACE THE TRANSFER SET BECAUSE THE OCCLUDER FEET ARE BROKEN, AND LEAKS CAN BE OBSERVED WHEN THE MINICAP IS REMOVED. THE REPORTED TRANSFER SET WAS PLACED ON 3/22/2006. NURSE STATED THAT THE HOSP HAS SWITCHED TO CHLORHEXIDE INSTEAD OF YODO PROVIDONE FOR CLEANING SOLUTION, BUT INCIDENTS STILL CONTINUE. THERE IS 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 H05B15082

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR