MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 16 CM; CATHETER PERCUTANEOUS

Catalog Number	CS-12122-F
Medical Device Problem Code	Material Too Soft/Flexible (4007)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).It was reported that the dilator tip was damaged.One sample was returned for evaluation.Visual inspection of the returned dilator identified signs of use, including the presence of biological material.The distal tip was observed to be split and folded.Microscopic examination confirmed the damage and revealed associated stress markings.Dimensional inspection was performed, and all measurable parameters, including overall length and outer and proximal inner diameters, were found to be within specification limits.The distal inner diameter could not be accurately measured due to the extent of the damage.Functional testing was conducted by advancing a guidewire through the dilator.Despite the damage to the distal tip, the guidewire passed through the lumen without resistance.A review of product drawings and instructions for use (ifu) was performed.The ifu includes a precaution against the use of excessive force during insertion, as this may result in component damage.A device history record (dhr) review was conducted for the relevant materials and batches.No nonconformances or manufacturing-related issues were identified that could be associated with the reported condition.The reported failure was confirmed based on the condition of the returned sample.However, the root cause could not be determined.F urther investigation has been initiated within the teleflex quality system to better understand this observation.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "the dilator is too soft.There was no reported patient harm or consequence.The device was replaced to complete the procedure successfully.".

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 16 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: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 24842887
• Report Number: 3006425876-2026-00468
• Device Sequence Number: 5664054
• Product Code: DQY
• UDI-Device Identifier: 00801902100108
• UDI-Public: (01)00801902100108(11)240214(17)290131(10)71F24B0233(21)
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/02/2026

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-12122-F
• Device Lot Number: 71F24B0233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2024
• 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