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	Material Deformation (2976)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
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 redq3857 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It reported the patient was admitted to the hospital for "recurrent fever for 1 month, nausea, vomiting, and acid reflux for 1 day".The patient underwent femoral vein puncture catheterization on (b)(6) 2021.During the operation, it was found that the guide wire in the dialysis catheter was difficult to remove, and the dialysis catheter was twisted, which caused heavy bleeding during the operation.The dialysis catheter was removed, and the operation area was pressurized and bandaged to stop bleeding.After the above treatment, the operation area bleeding stopped.Replace the surgical site again and perform femoral vein puncture and catheterization again.

• 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: 12107428
• Report Number: 3006260740-2021-02579
• Device Sequence Number: 17087407
• 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
• Device Implanted Year: 2021
• 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: REDQ3857
• 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: 07/02/2021
• 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: Required Intervention
• Patient Age: 32 YR