MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. POWER-TRIALYSIS CATHETER; CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED

Model Number	5613150
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Either the opening at the distal end of the catheter is too small, or the guidewire is unraveling/frayed.The team did not keep an example.The catheter won't thread all the way down the guidewire, and the guidewire cannot be removed from the patient once the catheter is positioned.

• Brand Name: POWER-TRIALYSIS CATHETER
• Common Device Name: CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.; 605 north 5600 west; salt lake city UT 84116
• MDR Report Key: 18606569
• Report Number: 18606569
• Device Sequence Number: 2722815
• Product Code: NIE
• UDI-Device Identifier: 00801741041945
• UDI-Public: (01)00801741041945
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/20/2023
• Report Date (Section F): 09/20/2023

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: 5613150
• Device Catalogue Number: 5613150
• Device Lot Number: REHN0906
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Other
• Date Report to Manufacturer: 01/30/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/30/2024
• 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: 09/20/2023