MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 NIAGARA DIALYSIS CATHETER KIT 13.5F X 15CM PRE-CURVED SHORT-TERM DL; CATHETER, HEMODIALYSIS, NON-IMPLANTED

Model Number	N/A
Medical Device Problem Codes	Component Incompatible (1108); Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of refq1929 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported doctor reported a faulty guide wire.The faulty guide wire got stuck during the procedure and the doctor was unable to advance it forward, also experienced difficulty removing it.
Event or Problem Description
It was reported doctor reported a faulty guide wire.The faulty guide wire got stuck during the procedure and the doctor was unable to advance it forward, also experienced difficulty removing it.
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 following were reviewed as part of this investigation: previous complaints, patient severity, applicable manufacturing records, submitted photograph, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint that the guidewire became stuck within the introducer needle was confirmed, but the exact cause was unknown.A photograph was provided for evaluation which depicted a guidewire within an 18ga introducer needle, all of which had been placed within a clear tray.It appeared that the guidewire direction had been reversed with the "j" tip distal end being proximal of the needle luer, and no guidewire could be seen to exit the needle tip which suggested that the guidewire had either become broken or was cut.No observable evidence suggested the cause of this event.Common historical cause includes inadvertent retraction of the guidewire against the needle bevel which can cause the guidewire to become stuck or damaged.A review of the manufacture records associated with the provided lot number found no potential cause identified during product manufacture.Should the physical sample be returned at a later time, this investigation will be updated.H3 other text: evaluation findings are in section h.11.

• Brand Name: NIAGARA DIALYSIS CATHETER KIT 13.5F X 15CM PRE-CURVED 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 14522483
• Report Number: 3006260740-2022-01996
• Device Sequence Number: 12378573
• Product Code: MPB
• UDI-Device Identifier: 00801741045608
• UDI-Public: (01)00801741045608
• Combination Product (Y/N): N
• Initial Reporter Country: KE
• PMA/510(K) Number: K090102
• 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): 07/30/2022

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 Model Number: N/A
• Device Catalogue Number: 5594150
• Device Lot Number: REFQ1929
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/04/2022
• Supplement Date Received by Manufacturer: 07/29/2022
• Initial Report FDA Received Date: 05/27/2022
• Supplement Report FDA Received Date: 08/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2021
• 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