MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS KIT: 2-L 15 FR X 23 CM; CATHETER, HEMODIALYSIS, IMPLA

Catalog Number	CS-15232-X
Medical Device Problem Codes	Material Separation (1562); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "doctor states dilator cap came off.She could not advance sheath." the user changed to a new set.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).
Additional Manufacturer Narrative
(b)(4).The customer submitted two photos for analysis.The images show a 16fr smartseal sheath/dilator assembly.In the image, the dilator is partially advanced through the sheath, and the dilator hub is separated from the dilator cap.Therefore, the complaint of dilator hub separation was able to be confirmed by the photos.The customer also returned one 16fr smartseal sheath/dilator assembly for analysis.Signs of use were observed.Upon receipt, the dilator had been partially advanced through the sheath.Visual analysis revealed that the dilator hub was separated from the dilator cap.No significant damage was noted to either the dilator hub or dilator cap.Microscopic examination revealed minor deformation of the distal tip of the peel away sheath.The dilator was removed from the sheath.The hemostasis valve was observed to be slightly displaced at the edges, however no significant damage was noted.No other defects were noted on the dilator body, dilator hub, or dilator cap.The returned sheath and dilator were tested per the instructions for use (ifu) provided with this kit.The ifu instructs the user, " insert tissue dilator into sheath until dilator cap folds over valve housing and secures dilator onto sheath assembly." the detached dilator cap was removed from dilator body.Then, the dilator was advanced through the sheath.Little to no resistance was experienced.The dilator cap was then reassembled onto the dilator hub.After assembly of the dilator hub and dilator cap, the connection was observed to be secure.The dilator cap was unable to be removed from the dilator hub without use of significant force.The dilator assembly was then advanced through the sheath until the dilator cap folded over the valve housing.Little to no resistance was experienced.The ifu also states, "separate dilator cap from sheath valve housing once the assembly is fully introduced into venous system.Rock the dilator cap off hub while stabilizing sheath by grasping hub assembly." the dilator cap was separated from the sheath valve housing and the dilator assembly was successfully removed from the sheath.R & d was contacted as part of this complaint investigation.They confirmed that the dilator is intended to remain in one piece during use.Additionally, it was stated that the observed defect may be due to assembly or molding defects.As this component is supplied, the root cause is supplier related.A device history record review was performed, and no relevant findings were identified.The ifu provided with this kit instructs the user "separate dilator cap from sheath valve housing once the assembly is fully introduced into venous system.Rock the dilator cap off hub while stabilizing sheath by grasping hub assembly." the customer report of dilator hub separation was confirmed by visual inspection of the customer supplied photos as well as investigation of the returned sample.Visual analysis of the returned sample revealed that the dilator cap was detached from the dilator hub.A device history record review was performed, and no relevant findings were identified.R & d was contacted as part of this complaint investigation, and it was determined that this is a supplier defect.A non-conformance has been initiated to further investigate this issue.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "doctor states dilator cap came off.She could not advance sheath." the user changed to a new set.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: ARROW HEMODIALYSIS KIT: 2-L 15 FR X 23 CM
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLA
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21993330
• Report Number: 9680794-2025-00436
• Device Sequence Number: 14607106
• Product Code: MSD
• UDI-Device Identifier: 00801902096302
• UDI-Public: (01)00801902096302(11)240305(17)270228(10)33F24A0916(21)
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K111117
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2025

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
• Device Catalogue Number: CS-15232-X
• Device Lot Number: 33F24A0916
• 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: 05/06/2025
• Supplement Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 06/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2024
• 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.; NOT REPORTED.
• Patient Sex: Unknown