BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3M AVI MODEL

    MDR report key: 51975 · Received July 5, 1996

    Report

    Report Number
    51975
    Event Type
    Injury
    Date Received
    July 5, 1996
    Date of Event
    March 19, 1996
    Report Date
    March 28, 1996
    Manufacturer
    3M/AVI
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    IV INFILTRATION OF INFANT. CAREGIVER WAS UNAWARE OF PROBLEM UNTIL NOTIFIED BY SUPERVISOR AND SYMPTOMS WERE ADVANCED. LEFT ARM TIGHT IN AXILLA, WAXY APPEARING UPPER ARM, MOTTLED FOREARM AND FINGER TIPS. PT WENT TO SURGERY FOR FASCIOTOMY. LONG TERM EFFECTS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3M AVI MODEL INFUSION PUMP FRN 3M/AVI 200A *

    Patients

    Seq Age Sex Outcome Treatment
    1 7 MO Required Intervention STD INFUSION SET WAS USED