FDA Adverse Event Death Summary report: N

TESIO LOCK RIGHT ADAPTOR

MDR report key: 168290 · Received May 18, 1998

Report

Report Number
168290
Event Type
Death
Date Received
May 18, 1998
Date of Event
February 11, 1998
Report Date
May 8, 1998
Manufacturer
MED COMP
Product Code
LFJ
Adverse Event
Yes
Report Source
User Facility report
Reporter Location
FL, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

PT FOUND AT HOME WITH MASSIVE BLEEDING FROM LEFT SUBCLAVIAN CATHETER DOUBLE PORT FOR DIALYSIS. ONE OF THE PORTS WAS BROKEN (BLUE). PT ARRIVED IN ER, INTUBATED, AND IN ASYSTOLE. PT EXPIRED 02/11/98 0238.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 TESIO LOCK RIGHT ADAPTOR TESIO EXTENSION LFJ MED COMP UNK UNK

Patients

Seq Age Sex Outcome Treatment
1 55 YR Death