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

Model Number	IPN920489
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "one half of the introducer sheath's hemostatic valve completely detached during catheter insertion, having been pushed into the sheath between the two branches.Since this half was no longer visible, and there was a risk of this structure entering the bloodstream if we continued inserting the catheter, it was necessary to remove the catheter, remove half of the hemostatic valve, and reinsert the catheter.There were no immediate complications, such as bleeding or air embolism, and the fact that part of the catheter was already inside the sheath prevented blood from leaking.The patient was reported as fine post the procedure.".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "one half of the introducer sheath's hemostatic valve completely detached during catheter insertion, having been pushed into the sheath between the two branches.Since this half was no longer visible, and there was a risk of this structure entering the bloodstream if we continued inserting the catheter, it was necessary to remove the catheter, remove half of the hemostatic valve, and reinsert the catheter.There were no immediate complications, such as bleeding or air embolism, and the fact that part of the catheter was already inside the sheath prevented blood from leaking.The patient was reproted as fine psot the procedure.".
Additional Manufacturer Narrative
(b)(4).The customer report of a damaged hemostasis valve was able to be confirmed through investigation of the returned sample.The customer returned one 16fr smartseal sheath and hemostasis valve from a hemodialysis kit for analysis.Signs of use were observed.Visual analysis revealed that the hemostasis valve was split down the middle.The valve remained in one piece.The sheath was split in two and no signs of resistance with splitting were noted.No other defects were observed.Additional information indicated that when the catheter was inserted into the sheath, the valve broke, with one part completely detaching from the sheath and accompanying the catheter.The insertion site was the right jugular, with no scar tissue at the site.No issues were reported with gaining access prior to sheath advancing in the vessel.A device history record review was performed, and one relevant finding was identified for which further actions were taken.Based on the investigation, it was determined that this damage is likely supplier related.Corrective actions were implemented by the supplier to address this issue.Notably, the affected component from this complaint was manufactured prior to the implementation of the corrective actions.

• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 23713583
• Report Number: 9680794-2025-01012
• Device Sequence Number: 10283124
• Product Code: MSD
• UDI-Device Identifier: 00801902096333
• UDI-Public: (01)00801902096333(11)241220(17)271130(10)33F24M0039(21)
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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): 11/12/2025

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: IPN920489
• Device Catalogue Number: CS-15242-VSP
• Device Lot Number: 33F24M0039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2025
• Supplement Date Received by Manufacturer: 12/12/2025
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2024
• 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