BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMITHS MEDICAL ASD INC

    MDR report key: 3525230 · Received December 13, 2013

    Report

    Report Number
    MW5033483
    Event Type
    Malfunction
    Date Received
    December 13, 2013
    Date of Event
    December 1, 2013
    Manufacturer
    SMITHS MED ASD
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPEATED OCCURENCE OF TUBING "OCCLUSION BELOW PUMP." WHEN TUBING REPLACED, PROBLEM CORRECTS. DATES OF USE: (B)(6) 2013. DIAGNOSIS OR REASON FOR USE: INFUSION SERVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652971 SMITHS MEDICAL ASD INC RC4203 IV ADMIN SET FPA SMITHS MED ASD 21-0445-25 JUL13T05

    Patients

    Seq Age Sex Outcome Treatment
    1 SITES| PRIMARY 2 LUER ACTIVATED NEEDLELESS INJECTION