MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-L 15 FR X 19 CM ANTE; CATHETER, HEMODIALYSIS, IMPLA

Catalog Number	CS-15192-VFIE
Medical Device Problem Codes	Material Separation (1562); Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "the doctor found the smartseal sheath valve damaged during used on the patient".They changed a new one to resolve the issue.No harm for the patient.The patient condition is fine.No medical intervention was required.The peel-away sheath tabs were also noted broken.The associated emdr report number 9680794-2025-00076.
Event or Problem Description
It was reported that "the doctor found the smartseal sheath valve damaged during used on the patient".They changed a new one to resolve the issue.No harm for the patient.The patient condition is fine.No medical intervention was required.The peel-away sheath tabs were also noted broken.The associated emdr report numbers are 9680794-2025-00092 and 9680794-2025-00076.
Additional Manufacturer Narrative
Qn# (b)(4).The actual device was not returned; however, the customer provided two photos of a peel-away hemostasis sheath for analysis.Visual analysis revealed that the sheath did not tear correctly.The sheath extrusion along the score line appeared wavy and non-uniform, indicating stretching.One side of the extrusion was observed to be separated from the remainder of the sheath body along with one of sheath hub tabs.Therefore, the customer report is confirmed.Manufacturing was contacted as part of this complaint investigation.It was confirmed that the observed incorrect tearing of the sheath is a supplier defect.The instructions for use (ifu) provided with this kit instructs the user, "sharply snap the tabs of valve housing in a plane perpendicular to the long axis of sheath to split valve and split sheath apart while withdrawing from vessel." the report of a sheath tearing incorrectly was confirmed by visual inspection of the customer supplied photos.Visual analysis of the photos revealed that the sheath did not tear correctly.The sheath extrusion along the score line appeared wavy and non-uniform, indicating stretching.Manufacturing was contacted as part of this complaint investigation, and it was confirmed 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.

• Brand Name: ARROW HEMODIALYSIS SET: 2-L 15 FR X 19 CM ANTE
• 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: 21264009
• Report Number: 9680794-2025-00092
• Device Sequence Number: 17294180
• Product Code: MSD
• UDI-Device Identifier: 10801902127195
• UDI-Public: (01)10801902127195(11)231012(17)260930(10)33F23K0169(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K141051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2025

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: 09/30/2026
• Device Catalogue Number: CS-15192-VFIE
• Device Lot Number: 33F23K0169
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2025
• Supplement Date Received by Manufacturer: 02/28/2025
• Initial Report FDA Received Date: 01/29/2025
• Supplement Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2023
• 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.
• Patient Sex: Unknown