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

Catalog Number	CS-15122-F
Medical Device Problem Codes	Difficult to Insert (1316); Difficult to Remove (1528); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported "on (b)(6) 2024, the doctor found it was difficult when the swg inserts and withdraws from the ars.The swg was found kinked during use on the patient." the user changed to a new set.There was no medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
Qn# (b)(4).The customer returned multiple components from a hemodialysis kit.No obvious signs of use were observed on any of the components.Visual analysis did not reveal any obvious defects or anomalies on the guide wire, the arrow raulerson syringe (ars), or the introducer needle.The guide wire length measured 685mm, which is within the specification limits of 678mm-688mm per the guide wire product drawing.The guide wire outer diameter measured 0.850mm, which is within the specification limits of 0.838mm-0.877mm per the guide wire product drawing.The guide wire was inserted through the returned ars/introducer needle subassembly.No resistance was encountered as the guide wire passed completely through the subassembly.Performed per ifu statement, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle".A device history record review was performed, and no relevant findings were identified.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." the ifu also states, "do not withdraw guidewire against needle bevel to reduce risk of possible severing or damaging of guidewire".The report of a kinked guide wire due to ars resistance was not confirmed through complaint investigation of the returned sample.No kinking was observed on the returned guide wire.Likewise, all relevant dimensional and functional requirements were met, and a device history record review did not reveal any relevant findings.Based on the customer report and the sample received, no problem was found with the returned device.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "on 12 sep 2024, the doctor found it was difficult when the swg inserts and withdraws from the ars.The swg was found kinked during use on the patient." the user changed to a new set.There was no medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM
• Common Device Name: CATHETER SUBCLAVIAN
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20398277
• Report Number: 3006425876-2024-00959
• Device Sequence Number: 6479956
• Product Code: LFJ
• UDI-Device Identifier: 00801902100146
• UDI-Public: (01)00801902100146(11)230816(17)280731(10)71F23H0583(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K895417
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2024

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 Catalogue Number: CS-15122-F
• Device Lot Number: 71F23H0583
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2024
• Supplement Date Received by Manufacturer: 11/08/2024
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2023
• 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: NONE REPORTED.; NONE REPORTED.
• Patient Sex: Unknown