BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP DISCONNECT CAP

    MDR report key: 782193 · Received November 2, 2006

    Report

    Report Number
    1423500-2006-01173
    Event Type
    Malfunction
    Date Received
    November 2, 2006
    Date of Event
    July 20, 2006
    Report Date
    October 31, 2006
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    RENAL PRODUCT SURVEILLANCE, QUALITY ENGINEERING, ALONG WITH PLANT MANUFACTURING, WILL CONTIUE TO MONITOR THIS PRODUCT LINE.

    Description of Event or Problem · 1

    A BAXTER PRODUCT SURVEILLANCE SPECIALIST RECEIVED PHONE CALL FROM THE HOME PATIENT'S (HP'S) NURSE. PER THE HP'S NURSE, THE HOME PATIENT NOTIIFED HIS PD NURSE ON 07/20/2006 THAT HIS MINICAP'S WERE FALLING OFF IN THE SHOWER. THE PROBLEM HAS NOT OCCURRED SINCE 07/20/2006. THERE ARE NO SAMPLES AVAILABLE FOR EVALUATION. NO PATIENT INJURY / MEDICAL INTERVENTION ASSOCIATED WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP DISCONNECT CAP DISCONNECT CAPS KDJ BAXTER HEALTHCARE CORPORATION NA NA01

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR