FDA Adverse Event Other Summary report: N

CT9000 INJECTOR

MDR report key: 373499 · Received January 17, 2002

Report

Report Number
1518293-2002-00001
Event Type
Other
Date Received
January 17, 2002
Report Date
December 12, 2001
Manufacturer
LIEBEL-FLARSHEIM
Product Code
DXT
Report Source
Manufacturer report
Reporter Location
SP
Reporter Occupation
INVALID DATA

Narratives

Description of Event or Problem · 1

NO PATIENT INJURY. CUSTOMER STARTED NORMAL INJECTION, BUT INSTEAD OF PROGRAMMED FLOW AND VOLUME, THE INJECTOR RAN AT HIGH SPEED, NOT STOPPING UNTIL END OF SYRINGE. PATIENT LINE AT CONNECTOR BROKE. HOSPITAL REPEATED WITHOUT PATIENT AND GOT SIMILAR RESULT. SERVICE REP. COULD NOT REPRODUCE PROBLEM.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 CT9000 INJECTOR ANGIOGRAPHIC INJECTOR & SYRINGE DXT LIEBEL-FLARSHEIM CT9000 *

Patients

Seq Age Sex Outcome Treatment
1 * Other