BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LANDMARK MIDLINE CATHETER

    MDR report key: 33972 · Received July 8, 1996

    Report

    Report Number
    MW1009454
    Event Type
    Injury
    Date Received
    July 8, 1996
    Date of Event
    May 10, 1996
    Report Date
    June 10, 1996
    Manufacturer
    MENLO CARE, INC.
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AFTER STANDARD STERILE PLACEMENT OF # 24G 6" CATHETER IN LEFT BASILIC VEIN AND FLUSHING OF CATHETER WITH 2CC NS, PT EXPERIENCED: "FEELING SAD," FACE FLUSHED, C.P. S.O.B., GRAY COLOR TO FACE, HBP, TACHYCARDIA WITHIN 5 MIN. CATHETER REMOVED IMMEDIATELY, 911 CALLED, PT IN SUPINE POSITION. PT TRANSPORTED TO ER WITHIN 15-30 MIN OF EPISODE, AFTER TREATMENT IN HOME BY PARAMEDICS. PT ADMITTED TO HOSP FOR R/O MI AND PE. ALL SYMPTOMS SUBSIDED AFTER 1-2 HRS IN HOSP. ALL DIAGNOSTIC TESTS IN HOSP WERE NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LANDMARK MIDLINE CATHETER MIDLINE INTRAVENOUS CATHETER FOZ MENLO CARE, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization