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

Model Number	FLEXD-150-SPK
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Hole in tubing; 150ml sterile disposable syringe.Fda safety report id# (b)(4).

• Brand Name: MEDRAD STELLANT FLEX
• Common Device Name: INJECTOR AND SYRINGE, ANGIOGRAPHIC
• Manufacturer (Section D): BAYER MEDICAL CARE INC.
• MDR Report Key: 15932900
• Report Number: MW5113663
• Device Sequence Number: 6392876
• Product Code: DXT
• UDI-Device Identifier: 00616258022833
• UDI-Public: 0100616258022833
• Combination Product (Y/N): N
• 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): 12/02/2022

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: FLEXD-150-SPK
• Device Lot Number: 8624693
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/06/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown