MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 NIAGARA DIALYSIS CATHETER KIT 13.5F X 15CM PRE-CURVED ST DL; CATHETER, HEMODIALYSIS, NON-IMPLANTED

Model Number	N/A
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2021
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 redw0141 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported the patient was admitted to the hospital on (b)(6) 2021.Hemodialysis was performed with a catheter in the right femoral vein on (b)(6) 2021.On (b)(6) 2021, it was found that the patient's femoral vein dialysis catheter did not return blood smoothly.The effect of repeated adjustments to the catheter position was not effective.Thus, removed and re-inserted.

• Brand Name: NIAGARA DIALYSIS CATHETER KIT 13.5F X 15CM PRE-CURVED ST DL
• 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: 12100688
• Report Number: 3006260740-2021-02535
• Device Sequence Number: 3652225
• Product Code: MPB
• UDI-Device Identifier: 00801741045608
• UDI-Public: (01)00801741045608
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K090102
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/17/2021

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: 5594150
• Device Lot Number: REDW0141
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/08/2021
• Initial Report FDA Received Date: 07/01/2021
• 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
• Patient Age: 37 YR