MAUDE Adverse Event Report: BAYER MEDICAL CARE, INC. MEDRAD® STELLANT STERILE DISPOSABLE SYRINGE; INJECTOR AND SYRINGE, ANGIOGRAPHIC

Model Number	SDS-CTP-SPK
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/17/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The ct department is experiencing leaking at the spike air vent when they are loading the iv contrast and saline on the medrad stellant sterile disposable syringe spikes.It leaks at the small round white air vent.This has occurred in approximately 20 air vents, all with the lot# of 8556158.There has been no patient impact.Manufacturer response for injector and syringe, angiographic, medrad stellant sterile disposable syringe (per site reporter) bayer is investigating.

• Brand Name: MEDRAD® STELLANT STERILE DISPOSABLE SYRINGE
• Common Device Name: INJECTOR AND SYRINGE, ANGIOGRAPHIC
• Manufacturer (Section D): BAYER MEDICAL CARE, INC.; 1 bayer drive; indianola PA 15051
• MDR Report Key: 8273152
• Report Number: 8273152
• Device Sequence Number: 11077581
• Product Code: DXT
• UDI-Device Identifier: 00616258007045
• UDI-Public: (01)00616258007045
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/21/2019
• Report Date (Section F): 01/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: SDS-CTP-SPK
• Device Catalogue Number: SDS-CTP-SPK
• Device Lot Number: 8556158
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/24/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/21/2019