STELLANT DUAL CT INJECTOR

Additional Manufacturer Narrative

A SYSTEM SERVICE CHECK REPORT OF THE MEDRAD® STELLANT FLEX CT INJECTION SYSTEM, SERIAL NUMBER (B)(6), COMPLETED MAY 22, 2025, VERIFIED IT WAS OPERATING WITHIN BAYER SPECIFICATION. THE MEDRAD® STELLANT FLEX DISPOSABLE SYRINGE KIT (FLEXD-150-SPK), LOT NUMBER 8665883, IN USE DURING THE PROCEDURE, WAS DISCARDED BY THE SITE; THEREFORE, IT IS NOT AVAILABLE FOR EVALUATION. BAYER PRODUCT ANALYSIS TESTED RETAINED SAMPLES OF THE FLEXD-150-SPK, BATCH NUMBER 8665883, AND CONCLUDED THAT THE RETAINED DISPOSABLES PERFORMED TO SPECIFICATION WITH NO PROBLEMS OBSERVED. AN OFFER FOR ADDITIONAL APPLICATIONS TRAINING WAS ACCEPTED BY THE SITE AND PERFORMED (B)(6) 2025. THIS INFORMATION DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, THE COMPANY, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO A REPORTABLE EVENT.

Description of Event or Problem

BAYER MEDICAL CARE WAS INFORMED THAT A 44-YEAR-OLD FEMALE SUFFERED AN EXTRAVASATION WHILE CONNECTED TO A MEDRAD® STELLANT FLEX CT INJECTION SYSTEM (SN (B)(6). THE CUSTOMER REPORTED THAT APPROXIMATELY 16 ML OF FLUID WAS EXTRAVASATED IN THE PATIENT'S RIGHT ANTECUBITAL. FOLLOWING THE EVENT, A WARM COMPRESS WAS APPLIED TO THE INFILTRATION SITE, A RADIOLOGIST ASSESSED THE PATIENT IV SITE, AND AN X-RAY WAS PERFORMED TO DOCUMENT THE EXTENT OF THE EXTRAVASATION. THE PATIENT IS REPORTED AS DOING WELL.