MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 NIAGARA SLIM-CATH DIALYSIS CATHETER KIT 12F X 15CM (STRAIGHT) (ST) (DL); CATHETER, HEMODIALYSIS, NON-IMPLANTED

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Alteration in Body Temperature (4568)
Date of Event	07/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported on (b)(6) 2023, due to chronic kidney disease stage 5 patient was admitted to the renal department, temporary catheterization of right internal jugular vein was performed on the same day.On (b)(6) 2023, left forearm arteriovenous fistula.On (b)(6) 2023, the hemodialysis process was smooth, the general condition was ok, patient was discharged from the department, transferred for regular hemodialysis (through the right internal jugular vein temporary tube).At the end of june, fever appeared shortly after hemodialysis, and she was hospitalized and reported anti-infection treatment.The specific course of treatment is unknown.On (b)(6) 2023, due to poor anti-infection treatment, she was hospitalized in eicu.On the day of admission, the right internal jugular vein catheter was removed and the right femoral vein temporary catheter (arrow) was placed.On (b)(6) 2032, transferred to renal department for further treatment.
Additional Manufacturer Narrative
H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The device has not been returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
It was reported on (b)(6) 2023, due to chronic kidney disease stage 5 patient was admitted to the renal department, temporary catheterization of right internal jugular vein was performed on the same day.On (b)(6) 2023, left forearm arteriovenous fistula.On (b)(6) 2023, the hemodialysis process was smooth, the general condition was ok, patient was discharged from the department, transferred for regular hemodialysis (through the right internal jugular vein temporary tube).At the end of june, fever appeared shortly after hemodialysis, and she was hospitalized and reported anti-infection treatment.The specific course of treatment is unknown.On (b)(6) 2023, due to poor anti-infection treatment, she was hospitalized in eicu.On the day of admission, the right internal jugular vein catheter was removed and the right femoral vein temporary catheter (arrow) was placed.On 07.10, transferred to renal department for further treatment.Additional information received 8/30/2023: it was reported the patient did not have any other signs of infection other than a fever.No blood cultures were drawn.Fever did not resolve after the dialysis catheter was removed.

• Brand Name: NIAGARA SLIM-CATH DIALYSIS CATHETER KIT 12F X 15CM (STRAIGHT) (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
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 17638704
• Report Number: 3006260740-2023-03725
• Device Sequence Number: 5590721
• Product Code: MPB
• UDI-Device Identifier: 00801741045356
• UDI-Public: (01)00801741045356
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K010778
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2025
• Device Model Number: N/A
• Device Catalogue Number: 5553150
• Device Lot Number: REGQ3802
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/30/2023
• Initial Report FDA Received Date: 08/28/2023
• Supplement Report FDA Received Date: 09/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown