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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Medrad syringe for contrast power injector broke during power injection.Fda safety report id# (b)(4).

• Brand Name: MEDRAD STELLANT STERILE DISPOSABLE SYRINGE
• Common Device Name: INJECTOR AND SYRINGE, ANGIOGRAPHIC
• Manufacturer (Section D): BAYER MEDICAL CARE INC.
• MDR Report Key: 11759809
• Report Number: MW5101095
• Device Sequence Number: 17143393
• Product Code: DXT
• UDI-Device Identifier: 00616258022130
• UDI-Public: (01)00616258022130
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 04/28/2021

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: Health Professional
• Device Expiration Date: 03/20/2025
• Device Model Number: SDS-CTP-SPK
• Device Catalogue Number: SDS-CTP-SPK
• Device Lot Number: 8597482
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1