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	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "on (b)(6) 2025, during insertion, the doctor found the swg kinked when pulling out from the ars." the user changed to a new set to resolve the issue.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and potential findings were identified; however, it could not be determined if the findings were relevant to the reported event without the device returned for evaluation.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
Event or Problem Description
It was reported "on (b)(6) 2025, during insertion, the doctor found the swg kinked when pulling out from the ars." the user changed to a new set to resolve the issue.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The customer returned one guide wire for analysis.No obvious signs of use were observed.The arrow raulerson syringe (ars) associated with this event was not returned.Visual analysis revealed that the guide wire was kinked.Microscopic examination confirmed the damage and revealed that the distal and proximal welds were full and spherical.The kink on the guide wire measured 77mm from the proximal weld.The guide wire length measured 602mm, which is within the specification limits of 596mm-604mm per the guide wire product drawing.The guide wire outer diameter measured 0.85mm, which is within the specification limits of 0.838mm-0.877mm per the guide wire product drawing.The guide wire was inserted through a lab inventory ars/18ga introducer needle subassembly.Resistance was encountered at the location of the kink; however, the rest of the guide wire passed with little to no resistance.Performed per ifu statement, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle".A manual tug test confirmed that the distal and proximal welds were secure and intact.A device history record review was performed, and potentially relevant findings were identified; however, it cannot be determined if the findings were relevant to the reported event without the ars also returned for evaluation.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 report of a kinked guide wire was confirmed through complaint investigation.Visual analysis revealed that the returned guide wire was kinked.Despite the damage the sample met all relevant dimensional requirements.Functional testing confirmed that the location of the kink meets resistance when being inserted through a lab inventory ars/introducer needle subassembly.As a full visual and functional analysis could not be performed on the actual ars involved with this complaint, the root cause cannot be determined at this time.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "on (b)(6) 2025, during insertion, the doctor found the swg kinked when pulling out from the ars." the user changed to a new set to resolve the issue.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21771899
• Report Number: 3006425876-2025-00333
• Device Sequence Number: 20882873
• Product Code: MPB
• UDI-Device Identifier: 00801902100269
• UDI-Public: (01)00801902100269(11)231123(17)251031(10)71F23L0697(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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/14/2025

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: 10/31/2025
• Device Catalogue Number: CU-23122-F
• Device Lot Number: 71F23L0697
• 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: 03/14/2025
• Supplement Date Received by Manufacturer: 05/01/2025; 06/06/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 05/09/2025; 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2023
• 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.; NOT REPORTED.; NOT REPORTED.
• Patient Sex: Unknown