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

Catalog Number	CS-15282-VSP
Medical Device Problem Code	Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "during the placement of a chronic dialysis catheter the compression sleeve (green component under the compression cap) did not attach properly.And thus, the vascular surgeon could not connect the catheter with the extension lines.The vascular surgeon used another compression sleeve (she had to open a repair kit) and this sleeve was fine and the placement of the catheter was successful".The patient is fine and had no harm or injury.
Additional Manufacturer Narrative
(b)(4) the customer submitted one photo for analysis.The image shows a connector assembly, compression fitting, and compression sleeve within a hemodialysis kit.No damage is visible to any components.The customer also returned one connector assembly for analysis.Signs of use were observed.Visual analysis revealed no defects or anomalies on the returned sample.Visual analysis of the compression cap and green compression sleeve was unable to be performed as they were not returned by the customer.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." a lab inventory compression cap and sleeve were threaded onto the connector assembly hub with little to no resistance.Once fully tightened the connection was secure.A device history record review was performed, and no relevant findings were identified.The ifu provided with this kit warns 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.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 customer report of a damaged compression sleeve could not be confirmed through investigation of the returned sample.The customer returned one connector assembly for analysis.No obvious defects or anomalies were observed, and the connector assembly passed all relevant functional testing.A device history record review was performed, and no relevant findings were identified.Without the compression cap and green compression sleeve returned to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "during the placement of a chronic dialysis catheter the compression sleeve (green component under the compression cap) did not attach properly.And thus, the vascular surgeon could not connect the catheter with the extension lines.The vascular surgeon used another compression sleeve (she had to open a repair kit) and this sleeve was fine and the placement of the catheter was successful".The patient is fine and had no harm or injury.

• 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: 21343921
• Report Number: 9680794-2025-00123
• Device Sequence Number: 13040632
• Product Code: MSD
• UDI-Device Identifier: 00801902096388
• UDI-Public: (01)00801902096388(11)240301(17)270228(10)33F24B0010(21)
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 01/23/2025

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 Catalogue Number: CS-15282-VSP
• Device Lot Number: 33F24B0010
• 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: 01/23/2025
• Supplement Date Received by Manufacturer: 03/13/2025
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 03/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2024
• 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