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	01/03/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The tubing for the medrad injector syringe would not screw down onto the injector head for contrast injection.Upon looking at the injector syringe tip, it was noticed that the tip was bent and flexible which prevents the tubing to properly connect for injection.

• 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: 7658478
• Report Number: 7658478
• Device Sequence Number: 2527317
• Product Code: DXT
• UDI-Device Identifier: 00616258005188
• UDI-Public: (01)00616258005188
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/03/2018
• Report Date (Section F): 06/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 8536877
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 1 MO
• Date Report to Manufacturer: 07/03/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/03/2018
• 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: 06/25/2018