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 Codes	Material Split, Cut or Torn (4008); Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "the customer complains that the catheters dont sealed when screwed together.They feel that the material of the sealing ring is brittle and is damaged when the catheter is screwed together.I have two examples that show that the rings are torn.There was no harm to the patients.".
Additional Manufacturer Narrative
(b)(4).The report of the sealing ring being damaged was confirmed through investigation of the returned sample.The customer returned one c ompression fitting and two compression sleeves for evaluation.Visual inspection revealed damage to the green compression sleeve in the form of a cut through the lumen but not completely around the sleeve.This likely caused the sealing issue reported.Dimensional testing was performed and all measurements were in specification except the distal inner diameter of the compression fitting when measured with calipers.The measurement was in specification limits with a pin gauge.During manufacturing inspection for this part, the measurement test method is a pin gauge confirming how this passed initial inspection.The measurement difference per test method is indicative of a concentricity issue rather than a dimensional issue.A device history record review was performed, and no relevant findings were identified.Based on the customer report and the sample received, it was concluded that this issue was related to design of the compression sleeve and cap junction.Further actions have been initiated under teleflex quality system to evaluate this issue.
Event or Problem Description
It was reported that: "the customer complains that the catheters dont sealed when screwed together.They feel that the material of the sealing ring is brittle and is damaged when the catheter is screwed together.I have two examples that show that the rings are torn.There was no harm to the patients.".

• 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, NC 27560
• MDR Report Key: 23777491
• Report Number: 9680794-2025-01039
• Device Sequence Number: 9992810
• Product Code: MSD
• UDI-Device Identifier: 10801902127355
• UDI-Public: (01)10801902127355(11)250222(17)280131(10)33F24M0237(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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2025

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 Catalogue Number: CS-15272-VFE
• Device Lot Number: 33F24M0237
• 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: 11/19/2025
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2025
• 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: NOT REPORTED.; NOT REPORTED.
• Patient Sex: Unknown