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

Model Number	IPN920517
Medical Device Problem Codes	Leak/Splash (1354); Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "green seal is too large.When the hub is tightened, the seal is pushed over the thread and leads to leakage (air is drawn during aspiration)." no patient harm reported.The issue was resolved by using a replacement hub.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The customer returned one, opened hemodialysis kit for analysis.The 2-lumen hemodialysis catheter assembly will be analyzed as part of this complaint investigation.Per the customer report, it was revealed.That the returned components are not the same sample involved with this complaint (representative sample).Visual examination revealed that the compression sleeve and compression cap were completely threaded on the connector assembly.After performing functional testing (see below), the compression cap was threaded off the assembly to analyze the compression sleeve.No defects or anomalies were observed.The luer's injection port and the compression cap contained no cracks or damage.The catheter 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 the 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.The compression cap was inserted over the compression sleeve towards the connection assembly and connected firmly.The cap was able to be reconnected as expected.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 defect in the catheter body/connector assembly 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.The catheter passed all relevant visual and functional testing, and a device history record review was performed with no relevant findings.Leak testing was performed on the returned representative catheter per bs en iso 10555-1, section 4.7.1 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 that "green seal is too large.When the hub is tightened, the seal is pushed over the thread and leads to leakage (air is drawn during aspiration)." no patient harm reported.The issue was resolved by using a replacement hub.The patient's condition is reported as fine.

• Brand Name: 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: 14701469
• Report Number: 9680794-2022-00381
• Device Sequence Number: 16678064
• Product Code: MSD
• UDI-Device Identifier: 30801902195556
• UDI-Public: 30801902195556
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2022

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: 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: 06/08/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2022
• Supplement Date Received by Manufacturer: 07/06/2022
• Initial Report FDA Received Date: 06/15/2022
• Supplement Report FDA Received Date: 07/07/2022
• 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: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown