MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-L 15 FR X 27 CM RETR; CATHETER, HEMODIALYSIS, IMPLA

Catalog Number	CS-15272-VFE
Medical Device Problem Code	Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "the customer complains that the catheters are no longer sealed after the sealing ring has been overwritten and the catheters have been screwed together.It has been found that the material of the sealing ring is probably too brittle and is damaged when the catheter is screwed together".No patient involvement.
Additional Manufacturer Narrative
(b)(4).The report of compression sleeve damage was confirmed through investigation of the returned sample and supplied photo/video.The cus tomer provided one photo and one video and returned one haemodialysis set for analysis.Visual analysis of the sample revealed the compression sleeve was torn and damaged on the threads of the connector assembly.No other defects or anomalies were observed.The observed sleeve damage is consistent with misalignment of the compression sleeve within the compression cap prior to twisting onto the connector assembly threads.Additional information indicated that the green compression sleeve was placed directly under the threads before the compression cap was applied.The ifu states "ensure compression sleeve is securely positioned inside threaded compression cap.Avoid attempts to place compression sleeve onto hub connection assembly cannula and then apply threaded compression cap.Incomplete compression may occur causing catheter separation".The ifu also states "slide threaded compression cap over compression sleeve towards hub connection assembly with compression sleeve seated completely inside." a device history record review was performed, and no relevant findings were identified.Based on the customer report, the returned sample, and the additional information received, unintentional use error likely caused or contributed to this event.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "the customer complains that the catheters are no longer sealed after the sealing ring has been overwritten and the catheters have been screwed together.It has been found that the material of the sealing ring is probably too brittle and is damaged when the catheter is screwed together".No patient involvement.

• Brand Name: ARROW HEMODIALYSIS SET: 2-L 15 FR X 27 CM RETR
• 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: 24251175
• Report Number: 9680794-2026-00052
• Device Sequence Number: 9657718
• Product Code: MSD
• UDI-Device Identifier: 10801902127355
• UDI-Public: (01)10801902127355(11)250627(17)280420(10)33F25E0349(21)
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K141051
• 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): 01/07/2026

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-15272-VFE
• Device Lot Number: 33F25C0049
• 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: 01/07/2026
• Supplement Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2025
• 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
• Patient Sex: Unknown