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

Catalog Number	CS-25122-F
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "on (b)(6) 2026, during insertion, the swg was found kinked during used on the patient.No harm for the patient.The patient condition is fine.No medical intervention was required.They changed a new one to resolve the issue.".
Additional Manufacturer Narrative
(b)(4).The customer provided one photo for analysis: the photo shows guidewire in a kinked condition with a misshapen j-band.The guidewire also appears positioned within the advancer of the guidewire tube assembly.The customer returned one guidewire and 2-lumen 12 fr x 20 cm catheter for analysis.Signs of use were observed on the guidewire and catheter.Four kinks were identified on the guidewire body, one of kink was located towards the j-bend region and another was observed towards proximal end.The distal j-bend was mishappened.Microscopic examination confirmed that proximal and distal welds were present and appeared full and spherical.The guidewire was functionally tested in accordance with the product instructions for use (ifu).The ifu provided with this kit instructs the user to "advance the guidewire into the arrow raulerson syringe approximately 10 cm until it passes through the syringe valves or into the introducer needle." functional testing was performed by advancing the guidewire through a laboratory inventory arrow raulerson syringe (ars) and a laboratory inventory 18-gauge introducer needle.Resistance was observed at the kinked locations; however, the undamaged portions of the guidewire advanced through the ars and introducer needle without resistance.A device history record review was performed, and no relevant findings were identified.The instructions-for-use (ifu) provided with the kit describes suggested techniques to minimize the likelihood of guide wire damage during use.The instructions caution, "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 that the guidewire was observed to be kinked during use was confirmed through investigation of the returned sample.Visual examination identified four kinks were identified on the guidewire body, one of kink was located towards the j-bend region and another was observed toward proximal end.The distal j-bend was mishappen.Signs of use were observed on the returned guidewire.The returned guide wire met all relevant dimensional/functional requirements, and a device history record review did not identify any manufacturing-related issues.Based on the condition of the guide wire and the report that the damage was observed during use, unintentional use error caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM
• Common Device Name: CATHETER HEMODIALYTSIS NON IMP
• 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: 24401049
• Report Number: 3006425876-2026-00199
• Device Sequence Number: 18574528
• Product Code: MPB
• UDI-Device Identifier: 00801902100207
• UDI-Public: (01)00801902100207(11)250815(17)270623(10)71F25H0564(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
• Report Date (Section B): 01/27/2026

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-25122-F
• Device Lot Number: 71F25H0564
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/15/2025
• 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
• Patient Sex: Unknown