MEDRAD STELLANT FLEX SYRINGE KITS
Received Mar 12, 2025 · Event occurred Feb 10, 2025
Report 2520313-2025-00008 · MDR key 21582422
Device
Generic name
Angiographic Injector And Syringe
Manufacturer
Bayer Medical Care Inc.Model number
87078752Catalog number
FLEXD-150-SPK
Lot number
8659907
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Back pain
- Back pain
Narrative
Additional Manufacturer Narrative
ALTHOUGH THE CUSTOMER DISCARDED THE SYRINGE KIT THAT WAS IN USE DURING THE INCIDENT, BAYER PRODUCT ANALYSIS RECEIVED AND EXAMINED AN UNUSED MEDRAD® STELLANT FLEX DISPOSABLE SYRINGE KIT FROM THE SAME LOT (FLEXD-150-SPK, LOT NUMBER 8659907) PROVIDED BY THE CUSTOMER. FUNCTIONAL TESTING OF THE UNUSED PRODUCTS CONFIRMED THAT THEY PERFORMED TO SPECIFICATION WITH NO LEAKS OBSERVED. THE DEVICE HISTORY RECORD (DHR) FOR BATCH NUMBER 8659907 WAS REVIEWED FOR ANY INDICATIONS OF NON-CONFORMITIES AS WELL AS ANY OTHER DEVIATIONS. THIS REVIEW CONCLUDED THAT THERE WERE NO NON-CONFORMITIES OR ALERT/ACTION LIMITS REACHED DURING THE IN-LINE INSPECTION OF THIS BATCH. 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
THE CUSTOMER REPORTED CONNECTION AND LEAKING ISSUES WHILE USING A MEDRAD® STELLANT FLEX DISPOSABLE SYRINGE KIT (FLEXD-150-SPK, LOT NUMBER 8659907). THE CONTRAST HAD LEAKED ONTO THE FLOOR UPON WHICH THE TECHNOLOGIST SUBSEQUENTLY SLIPPED AND FELL. AFTER BEING EVALUATED IN THE EMERGENCY ROOM, THE EMPLOYEE WAS RELEASED BACK TO WORK WITH NO ISSUES REPORTED.