MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 NIAGARA DIALYSIS CATHETER KIT 13.5F X 15CM; 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	08/24/2023
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 complaint of a stuck guidewire is confirmed and was determined to be use related.The product returned for evaluation was one kit tray containing one niagara catheter kit tray containing one 0.038 in.¿j¿-tip guidewire in a plastic hoop, one 18 g introducer needle, one 15 cm niagara catheter (stylet in blue lumen, pinch clamp on red lumen closed), two dualator dilators (13 fr & 14 fr), one attachable suture wing, and one heparin sticker.The investigation findings are consistent with damage caused by retraction of the guidewire against the bevel of the introducer needle.The returned product sample was evaluated, and the guidewire was confirmed to be broken which allowed the outer coil wire to become unraveled.Microscopic examination of the fracture sites revealed the following: narrowing of the wire cross-section near the fracture site, which is a characteristic feature of a strong pull on the wire damage to the inside edge of the introducer needle which can occur if the guidewire is forcefully retracted against the needle, damaging the shape of the sharpened bevel biological material was also seen on the wire which may have contributed to the observed guidewire fracture as retraction of the wire together with the biological material could have caused the pieces to become stuck.Normal movement of the guidewire is away from the sharpened bevel and will not damage the wire.If the guidewire direction is reversed, the guidewire is then pulled against the sharpened edge of the needle bevel and can cause shearing damage of the wire and/or cause the wire to become stuck within the needle.An examination of the wire structure revealed no potential damage/defect related to manufacture of the product.
Event or Problem Description
It was reported that when using the short-term dialysis catheter, the operator found that the guidewire could not pass through the needle prior to insertion into the patient.No other information was provided.01/16/2024: a guidewire was returned for evaluation and was found to be unraveled.

• Brand Name: NIAGARA DIALYSIS CATHETER KIT 13.5F X 15CM
• 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: 18665266
• Report Number: 3006260740-2024-00389
• Device Sequence Number: 18232085
• 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
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/26/2024

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: 5594150
• Device Lot Number: REGW0142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2024
• Initial Report FDA Received Date: 02/07/2024
• 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