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

Model Number	IPN920513
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, "one half of the introducer sheath's hemostatic valve completely detached during catheter insertion, having been pushed into the sheath between the two branches.Since this half was no longer visible, and there was a risk of this structure entering the bloodstream if we continued inserting the catheter, it was necessary to exteriorize the catheter, remove half of the hemostatic valve, and reinsert the catheter.There were no immediate complications, such as bleeding or air embolism, and the fact that part of the catheter was already inside the sheath prevented blood from leaking".No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, "one half of the introducer sheath's hemostatic valve completely detached during catheter insertion, having been pushed into the sheath between the two branches.Since this half was no longer visible, and there was a risk of this structure entering the bloodstream if we continued inserting the catheter, it was necessary to exteriorize the catheter, remove half of the hemostatic valve, and reinsert the catheter.There were no immediate complications, such as bleeding or air embolism, and the fact that part of the catheter was already inside the sheath prevented blood from leaking".No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The customer report of a detached hemostatic valve was able to be confirmed through investigation of the returned sample.The customer returned one 16fr smartseal sheath for analysis.Signs of use were observed.Visual analysis revealed that the sheath was fully split, however the two halves of the valve remained connected and were attached to one half of the sheath hub.A device history record review was performed, and no relevant findings were identified.The manufacturing unit confirmed that this issue is a supplier-related defect.Additionally, supplier quality confirmed that the deformation observed along the edge of the sheath body is considered normal and is not indicative of a defect.Based on the investigation of the returned sample and the comments from the manufacturing unit, the root cause of the reported issue is supplier related.Further investigation has been initiated under teleflex quality systems to evaluate this issue.Other remarks: n/a.Corrected data: n/a.

• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 24400193
• Report Number: 9680794-2026-00114
• Device Sequence Number: 18579048
• Product Code: MSD
• UDI-Device Identifier: 00801902096388
• UDI-Public: (01)00801902096388(11)250506(17)280406(10)33F25D0013(21)
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K111117
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2026

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 Model Number: IPN920513
• Device Catalogue Number: CS-15282-VSP
• Device Lot Number: 33F25D0013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2026
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Patient Sex: Unknown