MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 13 CM; CATEHTER HEMODIALYSIS NON IMPL

Catalog Number	CU-23122-F
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The customer provided one photo for analysis.The image displayed one guide wire assembly with the straightener tube and end cap missing.No damage can be observed in the photo.The customer also returned multiple components of a cvc kit, including one guide wire assembly and catheter, for analysis.Definite signs of use were observed.Visual inspection of the guide wire revealed one kink along the body.The j-bend was misshapen but intact.Microscopic examination confirmed the damage and revealed that the welds were present and spherical.Visual examination of the ars could not be performed as it was not returned.The kink in the guide wire measured 560mm from the proximal end.The overall length of the guide wire measured 601mm which is within the specification limits of 596-604mm per the guide wire product drawing.The outer diameter of the guide wire measured 0.844mm which is within the specification limits of 0.838-0.877mm per the guide wire product drawing.The guide wire was tested with a lab inventory ars/18ga introducer needle subassembly per the instructions-for-use (ifu) provided with this kit.The ifu states, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle".The guide wire was able to pass through the components with little to no resistance.Functional analysis of the ars could not be performed as it was not returned.A manual tug test confirmed that both welds were secure.The ifu provided with the kit informs 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".The customer report of resistance between the ars and guide wire could not be confirmed through investigation of the returned sample.Visual analysis of the guide wire revealed that it contained one kink.Despite this, the guide wire passed all relevant dimensional and functional requirements.Analysis of the ars could not be performed as it was not returned for analysis.Therefore, based on the customer report and without the ars returned, the potential root cause could not be confirmed at this time.Teleflex will continue to monitor and trend for reports.
Event or Problem Description
It was reported that: "(b)(6) 2024, the doctor found the swg / ars resistance during use on the patient.Involved 1 pc.No medical intervention was performed.The patient condition is fine.".

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 13 CM
• Common Device Name: CATEHTER HEMODIALYSIS NON IMPL
• 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: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20198091
• Report Number: 3006425876-2024-00931
• Device Sequence Number: 7584080
• Product Code: MPB
• UDI-Device Identifier: 00801902100269
• UDI-Public: (01)00801902100269(11)231121(17)250425(10)71F23L0409(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K993933
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/11/2024

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: 04/25/2025
• Device Catalogue Number: CU-23122-F
• Device Lot Number: 71F23L0409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2024
• Initial Report FDA Received Date: 09/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2023
• 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
• Patient Sex: Unknown