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

Model Number	FLEX-200-SPK
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
There have been 4 instances this week in that the hub of the extension tubing has separated from the tubing itself.Fda safety report id # (b)(4).

• Brand Name: MEDRAD STELLANT FLEX
• Common Device Name: INJECTOR AND SYRINGE, ANGIOGRAPHIC
• Manufacturer (Section D): BAYER MEDICAL CARE
• MDR Report Key: 12967551
• Report Number: MW5105937
• Device Sequence Number: 4292077
• Product Code: DXT
• UDI-Device Identifier: 00616258022819
• UDI-Public: (01)00616258022819
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 12/07/2021

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: 11/18/2025
• Device Model Number: FLEX-200-SPK
• Device Catalogue Number: 2021-09-18
• Device Lot Number: 8607967
• 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: 12/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose