BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PCA SET MINI-BORE WITH INTERNAL ANTI-SIPHON VALVE

    MDR report key: 16021 · Received September 12, 1994

    Report

    Report Number
    MW1003304
    Event Type
    Malfunction
    Date Received
    September 12, 1994
    Date of Event
    June 3, 1994
    Report Date
    September 1, 1994
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT HAD A DUAL LUMEN CENTRAL LINE WITH TPN INFUSING TO ONE PORT AND PCA TO THE BROWN PORT. PCA DISCONTINUED 6/3. WHEN TUBING FROM PCA TO CATHETER HUB WAS SEPARATED, MALE END OF TUBING BROKE OFF INTO HUB, RENDERING THIS PORT OF CATHETER USELESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PCA SET MINI-BORE WITH INTERNAL ANTI-SIPHON VALVE PCA SET MINI-BORE WITH INTERNAL ANTI-SIPHON VALVE FPA ABBOTT LABORATORIES 3559 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 *