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

Model Number	FLEXD-150-SPK
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/28/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly female with history of type 2 diabetes, hypertension and congestive heart failure.Patient was having a ct angio of chest, "injector was set to inject a patient at 5cc/sec with a total of 94cc, the saline flush worked fine, then when the contrast started only 1 cc was injected and then the syringe broke at the bottom.The injector was reloaded and patient's exam was then finished without further incident".

• 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: 9948502
• Report Number: 9948502
• Device Sequence Number: 16961902
• Product Code: DXT
• UDI-Device Identifier: 00616258010663
• UDI-Public: (01)00616258010663
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/30/2020
• Report Date (Section F): 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FLEXD-150-SPK
• Device Catalogue Number: FLEXD-150-SPK
• Device Lot Number: 8572367
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2020
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/06/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 98
• Date Report Sent to FDA: 01/30/2020