MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 NIAGARA SLIM-CATH DIALYSIS CATHETER KIT 12F X 20CM STRAIGHT, SHORT-TERM, DL; CATHETER, HEMODIALYSIS, NON-IMPLANTED

Catalog Number	5553200
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2024
Type of Reportable Event	Malfunction
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 manufacturer has received the sample and is pending evaluation.A supplemental will be submitted with evaluation results.
Event or Problem Description
It was reported that on 2024.9.1 the physician leaves a dialysis catheter in place for the patient to prepare for crrt treatment, and the guidewire fails to feed during the puncture process.Upon inspection, the guidewire is found to be bent, and the physician replaces it with a new dialysis catheter for the puncture, and the guidewire feeds normally, and the puncture is completed successfully.No other information provided, at this time.
Event or Problem Description
It was reported that on (b)(6) 2024, the physician leaves a dialysis catheter in place for the patient to prepare for crrt treatment, and the guidewire fails to feed during the puncture process.Upon inspection, the guidewire is found to be bent, and the physician replaces it with a new dialysis catheter for the puncture, and the guidewire feeds normally, and the puncture is completed successfully.No other information provided, at this time.
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 complaint of a bent guidewire is confirmed, but the exact cause could not be determined.One photograph of a bent guidewire was returned for evaluation.Inspection of the returned photograph showed blood use residues along the guidewire along with three observable bends in the guidewire.There were no distinguishing features in the photographs of the device which could aid in identification of a specific root cause.A review of the manufacture quality and inspection records for the implicated product batch indicated no issues potentially related to product manufacture, assembly, and packaging.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: NIAGARA SLIM-CATH DIALYSIS CATHETER KIT 12F X 20CM STRAIGHT, SHORT-TERM, 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: shelly gilbert ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 20321519
• Report Number: 3006260740-2024-05554
• Device Sequence Number: 7613462
• Product Code: MPB
• UDI-Device Identifier: 00801741045363
• UDI-Public: (01)00801741045363(11)230722(17)250430(10)REHT0887
• 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: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2024

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 Expiration Date: 04/30/2025
• Device Catalogue Number: 5553200
• Device Lot Number: REHT0887
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2024
• Supplement Date Received by Manufacturer: 12/30/2024
• Initial Report FDA Received Date: 09/27/2024
• Supplement Report FDA Received Date: 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2023
• 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: Other
• Patient Sex: Unknown