MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-L 15 FR X 55 CM RETR; CATHETER, HEMODIALYSIS, IMPLA

Model Number	IPN001181
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the surgeon placed the catheter on a patient via femoral access site and after hub connection was done there was a leakage from the hub area while testing the patency of the arterial and venous lines.The catheter was left in situ and the hub was replaced.No patient harm was reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
Qn# (b)(4).
Additional Manufacturer Narrative
Qn#(b)(4).The report of a leaking extension line was confirmed through complaint investigation.The customer provided one photo for analysis and returned one retrograde chronic hemodialysis catheter for analysis.Signs-of-use were observed in the compression fitting.It was observed that the catheter body was severed, and the severed end was not returned for analysis.Initial visual inspection of the catheter did not reveal any obvious defects or anomalies.However, the threaded compression cap was not completely threaded as some of the threads were visible.In addition, the proximal opening of the threaded compression cap was slightly deformed.Functional testing was performed per instruction-for-use (ifu) statement, "flush each catheter lumen with sterile normal saline for injection, to establish patency and prime lumen(s) and flush the irrigation tube".A flush test was performed on the sample received, and leaking was observed between the threaded compression cap and the juncture hub.The compression fitting was then completely threaded onto the juncture hub and the sample was leak tested per bs en iso which states, "there shall be no liquid leakage in the form of a falling drop of water at 300-320 kpa (43.5-46.4 psi) for 30 sec when tested per bs en iso ".Both extension lines were attached to the leak tester and the lines were pressurized to 300 kpa and held for 30 seconds.No leaking was observed which indicates that the device was functional when assembled correctly.This also confirmed that the slight warping of the compression cap did not affect the functionality of the device.Additionally, the ifu provided with the kit informs the user, "the separate hub connection assembly is then fastened to the proximal end of the catheter using a compression sleeve and threaded compression cap".It also states, "thread compression cap onto hub connection assembly firmly, but do not over tighten.There should be no threads visible on hub connection assembly".A device history record review was performed, and no relevant findings were identified.Based on the customer report and the sample received, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported the surgeon placed the catheter on a patient via femoral access site and after hub connection was done there was a leakage from the hub area while testing the patency of the arterial and venous lines.The catheter was left in situ and the hub was replaced.No patient harm was reported.The patient's condition is reported as fine.

• Brand Name: ARROW HEMODIALYSIS SET: 2-L 15 FR X 55 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: 17184755
• Report Number: 9680794-2023-00439
• Device Sequence Number: 15014821
• Product Code: MSD
• UDI-Device Identifier: 10801902112726
• UDI-Public: 10801902112726
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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): 05/25/2023

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: 11/30/2025
• Device Model Number: IPN001181
• Device Catalogue Number: CS-15552-VFE
• Device Lot Number: 13F22L0863
• 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: 05/25/2023
• Supplement Date Received by Manufacturer: 07/14/2023
• Initial Report FDA Received Date: 06/22/2023
• Supplement Report FDA Received Date: 07/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2022
• 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