BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRACATH W/WIRE STYLET

    MDR report key: 112750 · Received August 11, 1997

    Report

    Report Number
    112750
    Event Type
    Injury
    Date Received
    August 11, 1997
    Date of Event
    January 15, 1997
    Report Date
    January 22, 1997
    Manufacturer
    BECTON DICKINSON VASCULAR ACCESS, INC.
    Product Code
    DQO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    1/14/97 PULMONARY ARTERY LINE (P/A LINE) DECREASED WITH SIGNIFICANT BLEEDING AT SITE ON SKIN. 1/15/97 DISCOVERED P/A CATHETER TIP REMAINED WITH CHEST X-RAY AND THEN TO OR FOR INTRACARDIAC FOREIGN BODY REMOVAL, RE-DO STERNOTOMY, REMOVE P/A CATH. IRRIGATE CHEST, REPLACE LEFT CHEST TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRACATH W/WIRE STYLET Implant IV CATHETER/NEEDLE UNIT DQO BECTON DICKINSON VASCULAR ACCESS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO Hospitalization| R 14 FR CHEST TUBE X4 DEBAKEG DOUBLE VELOUR VSD| PATCH LOT #08H F0193