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

Model Number	IPN920517
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/08/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
Qn#(b)(4).Additional information was requested, but no additional information was available at the time of this report.The patient's cause of death was not provided.
Event or Problem Description
It was reported, "during the connection of the catheter to dialysis an air leak was observed at the level of the catheter.The dialysis session had to be stopped and the catheter removed in the operating room." it was reported the catheter was inserted on (b)(6) 2022 and was "well positioned" and "monitored by x-ray".The catheter was removed and a new catheter was inserted.Dialysis was completed with the new catheter.It was reported the patient died on (b)(6) 2022."the deceased of the patient is not linked to the catheter.The incident delayed the dialyse.".
Additional Manufacturer Narrative
(b)(4).Additional information was requested, but no additional information was available at the time of this report.The patient's cause of death was not provided.The customer returned one, unopened chronic hemodialysis kit for analysis.This contradicts the customer report that the defect was observed "during use".Therefore, it is being assumed that the returned sample is a representative sample.The representative kit was opened, and no defects or anomalies were observed on any of the components.The catheter from the representative kit was tested using a pressurized leak tester with the compression sleeve and cap fully threaded on the connector assembly.The returned catheter body was clamped and the lumens were connected to a lab leak tester.The sample was tested per bs en iso 10555-1, section 4.7.1 (amrq-000162 rev.04) 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-10555-1 annex c".The leak tester was pressurized to 300 kpa and held for 30 seconds.No leaks were observed.From the representative sample, the compression cap was inserted over the compression sleeve towards the connection assembly and connected firmly.A manual tug test on the connection was completed and the connection was secure.A device history record review was performed with no relevant findings.The ifu provided with the kit informs the user, "green compression sleeve must be present when threading compression cap onto hub connection assembly.Failure to do so may result in air embolism, blood loss or catheter separation".The ifu 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".The customer report of a leaking catheter was not able to be confirmed by complaint investigation of the returned sample.The actual device was not returned; however, the customer returned a representative sample.No defects or anomalies were observed on the representative catheter, and a device history record review was performed with no relevant findings.Leak testing was performed on the returned representative catheter and no leaks were observed.Based on the customer report and the sample received, the root cause cannot be determined as the actual device was not returned and the reported issue could not be reproduced with the representative sample.Teleflex will continue to monitor and trend for complaints of this nature.
Event or Problem Description
It was reported, "during the connection of the catheter to dialysis an air leak was observed at the level of the catheter.The dialysis session had to be stopped and the catheter removed in the operating room." it was reported the catheter was inserted on (b)(6) 2022 and was "well positioned" and "monitored by x-ray".The catheter was removed and a new catheter was inserted.Dialysis was completed with the new catheter.It was reported the patient died on (b)(6) 2022."the deceased of the patient is not linked to the catheter.The incident delayed the dialyse.".

• Brand Name: ARROW HEMODIALYSIS KIT: 2-L 15 FR X 23 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: 15509056
• Report Number: 9680794-2022-00608
• Device Sequence Number: 5069912
• Product Code: MSD
• UDI-Device Identifier: 30801902195556
• UDI-Public: 30801902195556
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K111117
• 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): 09/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2024
• Device Model Number: IPN920517
• Device Catalogue Number: CS-15232-X
• Device Lot Number: 13F21J0846
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2022
• Supplement Date Received by Manufacturer: 10/19/2022
• Initial Report FDA Received Date: 09/29/2022
• Supplement Report FDA Received Date: 10/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2021
• 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: HEMODIALYSIS.; HEMODIALYSIS.
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Sex: Unknown