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

Lot Number	8646566
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medrad stellant flex connector tube cracked during power injector saline flush.Syringes were loaded and primed per protocol, connector tubing connected to patient j-loop.As saline preflush was injecting saline began spraying out of syringe/tubing connection.

• 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: 19127656
• Report Number: MW5153917
• Device Sequence Number: 12468803
• Product Code: DXT
• 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): Unknown
• 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: 8646566
• 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 Age: 49 YR
• Patient Sex: Male