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

Catalog Number	CS-15232-VFE
Medical Device Problem Codes	Material Deformation (2976); Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "in time of implant, proximal locking screw was not working due to malfunctioning defect, inside the proximal locking screw, the thread was deformed.Blood leakage was found from junction.We had to open an another vector-flow 23cm to complete the procedure successfully.There was no harm, patient is absolutely fine and discharged from hospital.".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "in time of implant, proximal locking screw was not working due to malfunctioning defect, inside the proximal locking screw, the thread was deformed.Blood leakage was found from junction.We had to open an another vector-flow 23cm to complete the procedure successfully.There was no harm, patient is absolutely fine and discharged from hospital.".
Additional Manufacturer Narrative
(b)(4).The details of the complaint were reviewed.No unit was returned for evaluation.A video was shared confirming the difficulty in locking the compression cap over the juncture hub.It is unknown if there were any defects present that could have caused the interconnection issue.A device history record review was performed, and no relevant findings were identified.The customer stated the threads were deformed due to manufacturing defect.It is likely that there could be threading offset on the juncture hub.However, this cannot be confirmed with the video provided by the customer.Another unit was used to complete the case.No patient harm noted.Based on the information, the most likely root cause of the issue is undeterminable.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW HEMODIALYSIS SET: 2-L 15 FR X 23 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: 23509665
• Report Number: 9680794-2025-00922
• Device Sequence Number: 13230839
• Product Code: MSD
• UDI-Device Identifier: 10801902127256
• UDI-Public: (01)10801902127256(11)250214(17)280131(10)33F25A0004(21)
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K141051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2025

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-15232-VFE
• Device Lot Number: 33F25A0004
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2025
• 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