MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM; CATHETER PERCUTANEOUS

Catalog Number	CU-25122-F
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that"15 nov 2023, the swg was found kinked during use on the patient.Patient reported as good post procedure.
Event or Problem Description
It was reported that"(b)(6) 2023, the swg was found kinked during use on the patient.Patient reported as good post procedure.
Additional Manufacturer Narrative
(b)(4) the customer report of a kinked guide wire was confirmed through complaint investigation of the returned sample.The customer provided one photo and returned one guide wire, the product tray, and the product lidstock for evaluation.The guide wire was returned within the advancer tube and showed evidence of use.Visual inspection of the guide wire revealed several kinks towards the distal end of the body.Microscopic examination confirmed the damage.The distal j-bend was slightly misshapen but intact.Both welds were present and appeared to be full and spherical.The major kinks in the guide wire were located 18mm and 27mm via calibrated ruler from the distal end.The length of the guide wire measured 683mm via calibrated ruler which was within the specifications of 678-688mm per product drawing.The guide wire outer diameter (od) measured 0.84mm via calibrated caliper which was within the specifications of 0.838-0.877mm per product drawing.The returned guide wire was functionally tested per the instructions-for-use (ifu) provided with this kit which states, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle." the guide wire was advanced through a lab inventory ars and a lab inventory 18ga introducer needle to func tionally test the guide wire.The guide wire passed through both components with minimal resistance.A manual tug test confirmed the distal and proximal welds were intact.The instructions-for-use (ifu) provided with this kit warns the user, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained, and further consultation requested." a device history record review was performed with no relevant findings.Based on these circumstances, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.
Additional Manufacturer Narrative
(b)(4).In section d provided the full udi #.Udi related data quality updates only.
Event or Problem Description
It was reported that" (b)(6) 2023, the swg was found kinked during use on the patient.Patient reported as good post procedure.

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM
• Common Device Name: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: laura guadalupe gonzalez ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18316823
• Report Number: 3006425876-2023-01235
• Device Sequence Number: 6278262
• Product Code: DQY
• UDI-Device Identifier: 00801902100276
• UDI-Public: (01)00801902100276(11)221212(17)241017(10)71F22M0145(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/16/2023

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
• Device Expiration Date: 10/17/2024
• Device Catalogue Number: CU-25122-F
• Device Lot Number: 71F22M0145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2023
• Supplement Date Received by Manufacturer: 01/05/2024; Not provided
• Initial Report FDA Received Date: 12/13/2023
• Supplement Report FDA Received Date: 01/08/2024; 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown