MAUDE Adverse Event Report: C. R. BARD, INC. PROXIS¿ URETERAL ACCESS SHEATH; ENDOSCOPIC ACCESS OVERTUBE, GASTROENTEROLOGY-UROLOGY

Model Number	231035
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Unable to pass guidewire through luer lock hub.

• Brand Name: PROXIS¿ URETERAL ACCESS SHEATH
• Common Device Name: ENDOSCOPIC ACCESS OVERTUBE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd.; covington GA 30014
• MDR Report Key: 20771005
• Report Number: 20771005
• Device Sequence Number: 15454817
• Product Code: FED
• UDI-Device Identifier: 00801741101687
• UDI-Public: (01)00801741101687(17)270723(10)BMJUFM22
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/14/2024
• Report Date (Section F): 11/19/2024

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 Model Number: 231035
• Device Catalogue Number: 231035
• Device Lot Number: BMJUFM22
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/25/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/25/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 11/19/2024