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	Material Disintegration (1177)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "green silicone joint was non-permeable.Device was changed." additional information received reports "when the seal was inserted, the device disintegrated in a circular fashion".There was no clinical consequences for the patient.No medical intervention required.The patient's current condition is reported as unknown.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one compression sleeve and lidstock from a hemodialysis kit for analysis.Signs of use were observed.The connector assembly was not returned.Visual analysis revealed damage to one end of the compression sleeve.The sleeve appeared to be cut in a spiral pattern.Additionally, thread indentations were visible along the cut edge.The damage to the compression sleeve is consistent with the compression sleeve being misplaced within the compressing fitting/cap which would cause 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.The inner diameter of the compression sleeve measured 0.210" which is within the specification limits of 0.207"-0.213" per the extrusion product drawing.The outer diameter of the compression sleeve measured 0.2595" which is within the specification limits of 0.257"-0.263" per the extrusion product drawing.The length of the compression sleeve measured 0.3575" which is within the specification limits of 0.34"-0.36" per the extrusion product drawing.A device history record review was performed, and no relevant findings were identified.The instructions for use (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 damage to the compression sleeve was able to be confirmed through complaint investigation of the returned sample.The compression sleeve was damaged/torn upon return which is consistent with misalignment of the compression sleeve within the compression fitting/cap prior to twisting on the connector assembly.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 that "green silicone joint was non-permeable.Device was changed." additional information received reports "when the seal was inserted, the device disintegrated in a circular fashion".There was no clinical consequences for the patient.No medical intervention required.The patient's current condition is reported as unknown.

• 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: 21806988
• Report Number: 9680794-2025-00284
• Device Sequence Number: 7408632
• Product Code: MSD
• UDI-Device Identifier: 00801902096302
• UDI-Public: (01)00801902096302(11)240531(17)270531(10)33F24D1037(21)
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2025

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 Model Number: IPN920517
• Device Catalogue Number: CS-15232-X
• Device Lot Number: 33F24D1037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2025
• Supplement Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 04/09/2025
• Supplement Report FDA Received Date: 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2024
• 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