FDA Adverse Event Death Summary report: N

GROSHONG CATHETER (CENTRAL VENOUS)

MDR report key: 4999 · Received June 11, 1993

Report

Report Number
4999
Event Type
Death
Date Received
June 11, 1993
Date of Event
April 20, 1993
Report Date
April 22, 1993
Manufacturer
UNKNOWN
Product Code
DXG
Adverse Event
Yes
Report Source
User Facility report

Narratives

Description of Event or Problem · 1

PATIENT'S TUBE FEEDING WAS CONNECTED IN ERROR TO GROSHONG CENTRAL VENOUS CATHETER INSTEAD OF J-TUBE. THE PATIENT RECEIVED TUBE FEEDING FOR APPROXIMATELY TWENTY MINUTES VIA GROSHONG CATHETER. THE PATIENT BEGAN MOANING LOUDLY, BECAME UNRESPONSIVE, A CODE BLUE WAS INITIATED WHICH TIME THE ERROR WAS DISCOVERED. THE CODE WAS UNSUCCESSFUL AND THE PATIENT WAS DISCOVERED, THE TUBE FEEDING WAS DISCONNECTED FROM THE GROSHONG AND IV FLUIDS WERE SUBSEQUENTLY INFUSED. THE EVENT OCCURRED DUE TO USER ERRORINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE NOT USED AS LABELED/INDENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: VISUAL EXAMINATION. RESULTS OF EVALUATION: INCORRECT TECHNIQUE/PROCEDURE. CONCLUSION: USER ERROR CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE DISCARDED, OTHER. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 GROSHONG CATHETER (CENTRAL VENOUS) DXG UNKNOWN

Patients

Seq Age Sex Outcome Treatment
1 54 YR Death