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

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer "cannot advance catheter over guidewire, cannot retract guidewire through catheter.Raising guidewire was not possible (side j tip), afterwards other side of (straight side) guidewire could raise, dilate ok, catheter only able to slide 12 cm over guidewire.Wanted to remove guidewire but could not.Guidewire stuck in the catheter.Patient was in an uncomfortable position for much longer and had to be pricked several times." no other information was provided.4/18/2024 - the guidewire returned for evaluation revealed the core wire was broken at the j-tip.
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 difficulty advancing/retracting the guidewire is confirmed; however, the root cause could not be determined.The product returned for evaluation was a 12fr dual lumen niagara slimcath catheter and a j-tip guidewire.Use residue was observed on the catheter.The guidewire exhibited multiple bends and curved shape memory.A non-complainant 0.038¿ j-tip guidewire was advanced and retracted through both lumens.No resistance was observed during functional testing.Microscopic inspection of the guidewire revealed the core wire was broken at the j-tip.The weld tip was partially attached.The core wire was observed to be tapered which is typical of failures due to tensile stress.However, additional unknown factors may have contributed to the break in the core wire.This complaint will be recorded for future trending and monitoring purposes.H3 other text : evaluation findings are in section h.11.

• Brand Name: NIAGARA SLIM-CATH DIALYSIS CATHETER KIT 12F X 20CM (STRAIGHT)
• 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: kayla bevins ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 19226481
• Report Number: 3006260740-2024-01997
• Device Sequence Number: 20950714
• Product Code: MPB
• UDI-Device Identifier: 00801741045363
• UDI-Public: (01)00801741045363
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K010778
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/25/2024

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 Model Number: N/A
• Device Catalogue Number: 5553200
• Device Lot Number: REGT3741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2024
• Initial Report FDA Received Date: 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2022
• 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