MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS KIT: 2-L 15 FR X 19 CM; CATHETER, HEMODIALYSIS, IMPLA

Catalog Number	CS-15242-VSP
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The customer submitted one video for analysis.The video shows one hemodialysis catheter and connector assembly in use on a patient.The clinician gestures to the connection between the juncture hub of the connector assembly and the molded compression fitting, then tightens the compression fitting.They then aspirate blood through the arterial extension line.Multiple threads of the juncture hub are visible, indicating that the molded compression fitting is not properly secured.The customer also returned one connector assembly with attached compression fitting and compression sleeve.Signs of use were observed.Visual analysis revealed that the compression fitting was completely screwed onto the juncture hub of the connector assembly with no threads visible.The compression fitting was observed to have scratch marks.The compression fitting was removed from the connector assembly.The compression sleeve was observed to be damaged within the compression fitting.The damage to the compression sleeve is consistent with the compression sleeve being misplaced within the compressing fitting/cap which would result in the metal cannulas on the connector assembly to catch onto the edge of the compressing sleeve as the components are assembled.When the compression fitting/cap and sleeve are twisted onto the juncture hub, the compression sleeve can get damaged/caught in the threads resulting in a non-secure connection between the compression fitting and connector assembly.The returned connector assembly was tested per the instructions for use (ifu) provided with this kit.The ifu instructs the user, "slide threaded compression cap over compression sleeve towards hub connection assembly with compression sleeve seated completely inside.Thread compression cap onto hub connection assembly firmly, but do not over tighten.There should be no threads visible on hub connection assembly." the compression sleeve was reseated within the compression fitting , then reassembled onto the connector assembly.After proper assembly, the connection between the compression fitting and juncture hub of the connector assembly was observed to be secure.No threads of the juncture hub were visible after assembly.The assembly was then flushed with a lab inventory syringe filled with water.No leaking was observed from any part of the assembly.A device history record review was performed, and there was one potential finding.A non-conformance was initiated for batches 13c22j2457, 13c22d1983 , 13c22j2456, 13c22j1116, 13c22c0707, 13c22e0626 and 13c22d1984 in regard to "juncture hub leaked in use".Review of the non-conformance reveled that the failure mode of this complaint is not the same as/relevant to the non-conformance identified.The ifu provided with this kit warns the user, "warning: 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.Precaution: ensure compression sleeve is securely positioned inside threaded compression cap.Avoid attempts to place compression sleeve onto hub connection assembly cannula and then apply threaded compression cap.Incomplete compression may occur causing catheter separation." the complaint of non-secure connection between the compression fitting and connector assembly was able to be confirmed through review of customer provided media and complaint investigation of the returned sample.Visual analysis of the video provided by the customer revealed multiple threads of the juncture hub were visible, indicating improper connection.The compression sleeve was damaged upon return which is consistent with misalignment of the compression sleeve within the compression fitting/cap prior to twisting on the connector assembly.The ifu provided with this kit warns the user "precaution: ensure compression sleeve is securely positioned inside threaded compression cap.Avoid attempts to place compression sleeve onto hub connection assembly cannula and then apply threaded compression cap.Incomplete compression may occur causing catheter separation." based on the customer report and sample received, unintentional use error likely caused or contributed to the reported event.Teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
It was reported "we can see the juncture hub leak during use on the patient." the user changed to a new set to resolve the issue.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: ARROW HEMODIALYSIS KIT: 2-L 15 FR X 19 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: keona jones ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 22166348
• Report Number: 9680794-2025-00472
• Device Sequence Number: 7799267
• Product Code: MSD
• UDI-Device Identifier: 00801902096333
• UDI-Public: (01)00801902096333(11)230306(17)260228(10)33F23B0749(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K111117
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/20/2025

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
• Device Expiration Date: 02/28/2026
• Device Catalogue Number: CS-15242-VSP
• Device Lot Number: 33F23B0749
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 06/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2023
• 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.
• Patient Sex: Unknown