MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 NIAGARA SLIM-CATH DIALYSIS 12FX24CM; CATHETER, HEMODIALYSIS, NON-IMPLANTED

Model Number	5553240
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of redr0572 showed no other similar product complaint(s) from this lot number.Device not returned for evaluation.
Event or Problem Description
It was reported that the introducer needle leaked air during operations.The procedure was done normally after the introducer needle was replaced.No other information was provided.

• Brand Name: NIAGARA SLIM-CATH DIALYSIS 12FX24CM
• Common Device Name: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 10830691
• Report Number: 3006260740-2020-20490
• Device Sequence Number: 3254714
• Product Code: MPB
• UDI-Device Identifier: 00801741045370
• UDI-Public: (01)00801741045370
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K010778
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/28/2020

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: 5553240
• Device Catalogue Number: 5553240
• Device Lot Number: REDR0572
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/21/2020
• Initial Report FDA Received Date: 11/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other