BEUDAMED
    FDA Adverse Event Other Summary report: N

    CODAN U.S. CORPORATION

    MDR report key: 257725 · Received January 5, 2000

    Report

    Report Number
    MW1017859
    Event Type
    Other
    Date Received
    January 5, 2000
    Date of Event
    December 16, 1999
    Report Date
    January 5, 2000
    Manufacturer
    CODAN US CORP
    Product Code
    FPA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    3:45PM FOUND SILVER DOLLAR SIZED WET SPOT IN PT'S BED UNDER Y-CONNECTOR. ATTEMPTED TO FLUSH PICC LINE. PICC LINE CLOTTED, REMOVED AND RESTART PERIPHERAL IV. PICC REPLACED ON 4TH ATTEMPT; 2 ON 12/18 AND 2 ON 12/24. INTERIM REQUIRED MULTIPLE PERIPHERAL IV STICKS. LOT# OF Y-CONNECTOR IN EXCHANGE "CART DRAWER" ON 12/16/99 WAS #70803. CODAN SHOULD NOT HAVE SENT THIS LOT# RELATED TO PRIOR COMPLAINT (AUGUST 99) FROM THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CODAN U.S. CORPORATION MINIBORE Y-CONNECTOR EXTENSION FPA CODAN US CORP * 70803

    Patients

    Seq Age Sex Outcome Treatment
    1 36 DAY Other