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

Lot Number	8648466
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medrad stellant flex tubing cracking/leaking.No harm to patient.

• Brand Name: MEDRAD STELLANT FLEX CT CONNECTOR TUBING
• Common Device Name: INJECTOR AND SYRINGE, ANGIOGRAPHIC
• Manufacturer (Section D): BAYER MEDICAL CARE INC.
• MDR Report Key: 19127762
• Report Number: MW5153921
• Device Sequence Number: 6825726
• Product Code: DXT
• UDI-Device Identifier: 00616258022833
• UDI-Public: (01)00616258022833
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 04/12/2024

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 Lot Number: 8648466
• 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: 04/16/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown