BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERLINK SOLN SET INJ. SITE L/L 60 DPM

    MDR report key: 313533 · Received January 19, 2001

    Report

    Report Number
    6000001-2001-00017
    Event Type
    Malfunction
    Date Received
    January 19, 2001
    Date of Event
    January 1, 2001
    Report Date
    January 17, 2001
    Manufacturer
    SINGAPORE (IVS)
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PER SALES REP, ACCOUNT REPORTS "TUBING SPLITTING ABOVE THE Y-SITE" WHILE BEING USED IN CT WITH A PRESSURE PUMP DELIVERING MEDS AT 150-300 PSI. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2668 INTERLINK SOLN SET INJ. SITE L/L 60 DPM INTERLINK BASIC SET FPA SINGAPORE (IVS) NA NA01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN