BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERLINK

    MDR report key: 359385 · Received October 31, 2001

    Report

    Report Number
    1911916-2001-00002
    Event Type
    Injury
    Date Received
    October 31, 2001
    Date of Event
    September 3, 2001
    Report Date
    October 29, 2001
    Manufacturer
    BECTON DICKINSON DIVISION
    Product Code
    FPA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NURSE DISCONNECTED I.V. LINE FROM PRIMARY LINE GOING TO I.J. CORDIS. WHEN NURSE CHECKED PT 15 MINUTES LATER, DISCOVERED THAT THE TIP FROM I.V. CONNECTOR BROKE IN I.V. LINE. APPROX 500CC OF BLOOD LOSS. BLOOD PRESSURE DROPPED TO 86/50 FROM 110/63. 2 UNITS OF PACKED RED BLOOD CELLS TRANSFUSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48751 INTERLINK LEVER LOCK CANNULA FPA BECTON DICKINSON DIVISION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention