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

Catalog Number	CS-15242-VSP
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "the compression sleeves that are supposed to slide over the cath are splitting.It was thought to be a random issue, but it has happened a couple times now with the doctor.It happened today in the case and he had to open another box just for the green sleeves.This has happened to two other kits to get a green compression sleeve that would work.Total opened 3 kits for one patient." additional information received clarifies the device split once it was opened so another kit was required.The subsequent device split as well and second kit was required.There was no medical intervention required.The patient's current condition is reported as "unknown".Associated mdr numbers include: 9680794-2025-00469, 9680794-2025-00470, and 9680794-2025-00471.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "the compression sleeves that are supposed to slide over the cath are splitting.It was thought to be a random issue, but it has happened a couple times now with the doctor.It happened today in the case and he had to open another box just for the green sleeves.This has happened to two other kits to get a green compression sleeve that would work.Total opened 3 kits for one patient." additional information received clarifies the device split once it was opened so another kit was required.The subsequent device split as well and second kit was required.There was no medical intervention required.The patient's current condition is reported as "unknown".Associated mdr numbers include: 9680794-2025-00469, 9680794-2025-00470, and 9680794-2025-00471, and 9680794-2025-00553.

• Brand Name: ARROW HEMODIALYSIS KIT: 2-L 15 FR X 19 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: 22212346
• Report Number: 9680794-2025-00553
• Device Sequence Number: 21020057
• Product Code: MSD
• UDI-Device Identifier: 00801902096333
• UDI-Public: (01)00801902096333(11)241220(17)271130(10)33F24M0039(21)
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K111117
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2025

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-15242-VSP
• Device Lot Number: 33F24M0039
• 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: 06/11/2025
• Supplement Date Received by Manufacturer: 07/01/2025
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2024
• 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