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

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2024
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 device has not been returned to the manufacturer for evaluation.
Event or Problem Description
It was reported that a large number of bubbles appeared when using the dialysis catheter.Confirm that the position is correct.When unplugging, a large number of bubbles appeared when pumping water.There was a problem with the reverse flow of the catheter.There was a problem with the catheter.No other information was provided.
Event or Problem Description
It was reported that a large number of bubbles appeared when using the dialysis catheter.Confirm that the position is correct.When unplugging, a large number of bubbles appeared when pumping water.There was a problem with the reverse flow of the catheter.There was a problem with the catheter.No other information was provided.
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 damaged catheter is inconclusive due to the state of the returned sample.Three photographs of a niagara slimcath were returned for evaluation.An initial visual observation of one of the photographs showed what appeared to be a niagara slimcath in a plastic bag.Use residues were observed on the sample in the returned photograph.No damage or details of the device in the returned photograph.Inspection of the returned photographs was insufficient to identify the alleged issue or a root cause of the reported issue.Therefore, this complaint is inconclusive at this time.This complaint will be recorded for future trending and monitoring purposes.
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 air infiltration was not confirmed because the problem could not be reproduced.The product returned for evaluation was a 20cm dual lumen niagara slimcath catheter.Use residue was observed on the sample.An attempt to flush the catheter with water using a 12ml syringe revealed the catheter was patent to infusion and aspiration with no observed leaks.Microscopic inspection of the catheter did not reveal any damage or deficiencies.The complaint of air infiltration was not reproduced during evaluation of the sample.However, clinical conditions that cannot be reproduced may have contributed.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported that a large number of bubbles appeared when using the dialysis catheter.Confirm that the position is correct.When unplugging, a large number of bubbles appeared when pumping water.There was a problem with the reverse flow of the catheter.There was a problem with the catheter.No other information was provided.

• Brand Name: NIAGARA SLIM-CATH DIALYSIS CATHETER KIT 12F X 20CM (STRAIGHT) (SHORT-TERM)
• 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: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 19805904
• Report Number: 3006260740-2024-03930
• Device Sequence Number: 18023687
• Product Code: MPB
• UDI-Device Identifier: 00801741045363
• UDI-Public: (01)00801741045363(17)250430(10)REGW1880
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K010778
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/14/2024

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: Other
• Device Expiration Date: 04/30/2025
• Device Model Number: N/A
• Device Catalogue Number: 5553200
• Device Lot Number: REGW1880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2024
• Supplement Date Received by Manufacturer: 07/29/2024; 10/14/2024
• Initial Report FDA Received Date: 07/23/2024
• Supplement Report FDA Received Date: 08/01/2024; 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2022
• 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: Other
• Patient Sex: Unknown