BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LANDMARK MIDLINE CATHETER (20 GAUGE)

    MDR report key: 36156 · Received August 21, 1996

    Report

    Report Number
    36156
    Event Type
    Injury
    Date Received
    August 21, 1996
    Date of Event
    August 16, 1996
    Report Date
    August 20, 1996
    Manufacturer
    MENLO CARE INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CATHETER WAS INSERTED IN LEFT AC (SAPHENOUS VEIN). DURING INSERTION THE LOCK ENGAGED AND WOULD NOT ALLOW THE CATHETER TO ADVANCE. THE COVER OVER THE CATHETER SEPARATED AND EXPOSED THE STERILE CATHETER. THE LINE WAS TAPED IN PLACE WITH GOOD BLOOD RETURN AT THREE (3") INCHES. THE IV INFILTRATED AND WAS DC'D. IT WAS THEN FOUND THAT THE LOCK HAD FAILED AND THE CATHETER HAD BEEN PULLED OUT. PT WAS IN DKA AND REQUIRED NA BICARB DRIP AND IV POTASSIUM CHLORIDE. PT WAS IN CRITICAL CONDITION AND WITH INABILITY TO LOCATE ANOTHER APPROPRIATE IV SITE, PHYSICIAN TRANSFERRED PT TO ANOTHER ACUTE CARE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LANDMARK MIDLINE CATHETER (20 GAUGE) IV CATHETER FOZ MENLO CARE INC. NA 601302M

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Life Threatening| R