MAUDE Adverse Event Report: BARD ACCESS SYSTEMS NIAGARA SHORT TERM DIALYSIS CATHETER 13.5F FULL PROCEDURE TRAY (15 CM); CATHETER, HEMODIALYSIS, NON-IMPLANTED

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation, as the device was discarded after the event occurred.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported patient had non-tunnelled catheter placed on 9/9.Confirmed placement prior to use.It was stated "accessed red lumen at 1210 and unclamped clamp and slid part up the line.Pulled back on syringe and only air was obtained.Upon closer inspection, hold noted in red lumen line that was underneath clamp.Clamped immediately and notified team.New line placed at bed side over guide wire and procedure is currently under way.".

• Brand Name: NIAGARA SHORT TERM DIALYSIS CATHETER 13.5F FULL PROCEDURE TRAY (15 CM)
• Common Device Name: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9137022
• Report Number: 3006260740-2019-02872
• Device Sequence Number: 19638694
• Product Code: MPB
• UDI-Device Identifier: 00801741045493
• UDI-Public: (01)00801741045493
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K030268
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/30/2019

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: N/A
• Device Catalogue Number: 5575150
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2019
• Initial Report FDA Received Date: 09/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 24 YR
• Patient Weight: 63