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 Codes	Material Frayed (1262); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the wire is stuck and cannot be pulled out.No other information was provided.It was reported this occurred with two devices.This report addresses the first device.
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 date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The manufacturer has received the sample and is pending evaluation.Results are expected soon.
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 guidewire is confirmed; however, the root cause could not be determined.One photograph of a guidewire was returned for evaluation.An initial visual observation of the photograph showed a guidewire contained in a plastic bag.Use residue was observed on the guidewire in the returned photograph.The coil wire was unraveled and elongated, indicating the core wire was broken.Although a damaged guidewire was evident in the submitted photograph, inspection of the photograph was insufficient to identify the cause of the damage.Consequently, this complaint is confirmed as ¿cause unknown¿ at this time.This complaint will be recorded for future trending and monitoring purposes.H3 other text : evaluation findings are in section h11.
Event or Problem Description
It was reported that the wire is stuck and cannot be pulled out.No other information was provided.It was reported this occurred with two devices.This report addresses the first device.

• 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: 18544634
• Report Number: 3006260740-2024-00124
• Device Sequence Number: 12743475
• Product Code: MPB
• UDI-Device Identifier: 00801741045363
• UDI-Public: (01)00801741045363
• 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
• Report Date (Section B): 04/08/2024

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: 02/28/2025
• Device Model Number: N/A
• Device Catalogue Number: 5553200
• Device Lot Number: REGQ1654
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/01/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2024
• Supplement Date Received by Manufacturer: 04/08/2024
• Initial Report FDA Received Date: 01/19/2024
• Supplement Report FDA Received Date: 04/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Other
• Patient Sex: Unknown