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

Model Number	FLEXD-150-SCS
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
Medrad stellant flex syringes are constantly leaking contrast when in use.Contacted (b)(4) and stated lot 8586385 has known issues, and all supply should be pulled from being used.Fda safety report id# (b)(4).

• Brand Name: BAYER MEDRAD STELLANT FLEX SYRINGES
• Common Device Name: INJECTOR AND SYRINGE, ANGIOGRAPHIC
• Manufacturer (Section D): BAYER MEDICAL CARE, INC. ; indianola PA 15051 0780
• MDR Report Key: 10770196
• Report Number: MW5097577
• Device Sequence Number: 11733533
• Product Code: DXT
• UDI-Device Identifier: 00616258022888
• UDI-Public: (01)00616258022888
• Initial Reporter State: OK
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/28/2020

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: 07/09/2024
• Device Model Number: FLEXD-150-SCS
• Device Catalogue Number: FLEXD-150-SCS
• Device Lot Number: 8586385
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1