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	12/11/2017
Type of Reportable Event	Malfunction
Event or Problem Description
When drawing up iv contrast, the spike would not detach from the syringe causing it to malfunction.Manufacturer response: for sterile disposable syringe, medrad (per site reporter) will review and respond.
Event or Problem Description
When drawing up iv contrast, the spike would not detach from the syringe causing it to malfunction.Manufacturer response for sterile disposable syringe, medrad (per site reporter): will review and respond.

• Brand Name: MEDRAD STELLANT STERILE DISPOSABLE SYRINGE
• Common Device Name: INJECTOR AND SYRINGE, ANGIOGRAPHIC
• Manufacturer (Section D): BAYER MEDICAL CARE INC.; 1 bayer drive; indialola PA 15051 0780
• MDR Report Key: 7128021
• Report Number: 7128021
• Device Sequence Number: 977756
• Product Code: DXT
• UDI-Device Identifier: 00616258005188
• UDI-Public: (01)00616258005188
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2017
• Report Date (Section F): 12/11/2017

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 Expiration Date: 11/04/2021
• Device Model Number: SDS-CTP-SPK
• Device Catalogue Number: SDS-CTP-SPK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2017
• Was the Report Sent to FDA?: Yes
• Device Age: 2 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/11/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/19/2017
• Supplement Report FDA Received Date: 12/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NO; NO OTHER THERAPIES
• Patient Age: 78 YR
• Patient Weight: 138
• Date Report Sent to FDA: 12/11/2017