BEUDAMED
    FDA Adverse Event Summary report: N

    MIDLINE CATHETER

    MDR report key: 54400 · Received July 16, 1996

    Report

    Report Number
    54400
    Date Received
    July 16, 1996
    Date of Event
    December 26, 1995
    Report Date
    January 5, 1996
    Manufacturer
    MENLO CARE, INC.
    Product Code
    FOZ
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    AS MIDLINE CATHETER WAS BEING INSERTED, APPROX 1 1/2 INCHES HAD BEEN THREADED WHEN SYMPTOMS BEGAN. PT COMPLAINED OF BACK PAIN AND FACE TURNED RED DOWN TO THE NECK. PT BECAME ANXIOUS IN BED AND SHORTLY THEREAFTER LOST RED FACE AND NECK BECAME A MOTTLED PURPLE CAST WITH COMPLAINTS OF SHORTNESS OF BREATH STATING "CAN'T BREATHE." ALSO COMPLAINED OF BACK HURTING AND SOME CHEST PAIN. MIDLINE CATHETER IMMEDIATELY REMOVED WHEN PT COMPLAINED OF SHORTNESS OF BREATH. PRESSURE APPLIED TO DISCONTINUED MIDLINE SITE. BP 108/64 P-88 R-18. PT THEN REGAINED PREINSERTION PALE COMPLEXION. CHARGE NURSE AND PHYSICIAN IMMEDIATELY NOTIFIED AND IMMEDIATELY IN TO EVALUATE PT. MD STATED HE FELT IT WAS A REACTION TO THE CATHETER. BENADRYL 25 MG. IVP GIVEN. AFTER THE PT'S COURSE OF HOSP TREATMENT FOR CROHN'S DISEASE AND A SMALL BOWEL OBSTRUCTION, THE PT WAS DISCHARGED WITHOUT COMPLICATIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *