MAUDE Adverse Event Report: BAYER MEDICAL CARE INC. MEDRAD STELLANT FLEX DISPOSABLE SYRINGES WITH SPIKES; INJECTOR AND SYRINGE, ANGIOGRAPHIC

Model Number	LEXD-150-SPK
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Medrad stellant flex syringe opened for use on injector tubing in the kit was broken at the syringe connection.

• Brand Name: MEDRAD STELLANT FLEX DISPOSABLE SYRINGES WITH SPIKES
• Common Device Name: INJECTOR AND SYRINGE, ANGIOGRAPHIC
• Manufacturer (Section D): BAYER MEDICAL CARE INC.
• MDR Report Key: 16398912
• Report Number: MW5115019
• Device Sequence Number: 16966587
• Product Code: DXT
• UDI-Device Identifier: 00616258022833
• UDI-Public: (01)00616258022833
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/15/2023

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 Model Number: LEXD-150-SPK
• Device Catalogue Number: FLEXD-150-SPK
• Device Lot Number: 8626462
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/16/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown