MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC HEMODIALYSIS KIT: 2-L 15 FR X 27 CM; CATHETER, HEMODIALYSIS, IMPLA

Model Number	IPN920484
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "by opening the cvc lumens and infusing a syringe of saline solution into them, blood and saline leakage was observed at the level of the connecting hub between the cvc lumens and the cvc itself.Upon opening the hub, the gasket appeared torn, resulting in the inability to ensure a proper airtight seal of the lumens to the cvc.The lumens, gasket, and hub were therefore replaced with new components, resolving the issue." no reported patient harm.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).Complaint details were reviewed.Customer stated, "by opening the cvc lumens and infusing a syringe of saline solution into them, blood and saline leakage was observed at the level of the connecting hub between the cvc lumens and the cvc itself.Upon opening the hub, the gasket appeared torn, resulting in the inability to ensure a proper airtight seal of the lumens to the cvc.The lumens, gasket, and hub were therefore replaced with new components, resolving the issue." one nextstep catheter connector body assembly, including a compression cap and two sleeves, was returned for evaluation.Inspection showed that the first sleeve was severely deformed and fractured, having split into two separate pieces-one remaining over the juncture hub threads and the other completely detached.In contrast, the second sleeve was examined and found to be intact with no signs of damage.The presence of a damaged seal is indicative of an improper connection at the junction hub.It is likely that the sleeve was positioned over the threads prior to cap installation, resulting in the sleeve being pinched between the threaded interfaces.Per the instructions for use, the following guidance was noted: warning: the green compression sleeve must be present when threading the compression cap onto the hub connection assembly.Failure to do so may result in air embolism, blood loss, or catheter separation.Thread the compression cap onto the hub connection assembly firmly, but do not overtighten.No threads should be visible on the hub connection assembly.Precaution: ensure the compression sleeve is securely positioned inside the threaded compression cap.Avoid attempts to place the compression sleeve onto the hub connection assembly cannula and then apply the threaded compression cap, as incomplete compression may occur and cause catheter separation based on the information, the most likely root cause of the issue is unintended use error.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: "by opening the cvc lumens and infusing a syringe of saline solution into them, blood and saline leakage was observed at the level of the connecting hub between the cvc lumens and the cvc itself.Upon opening the hub, the gasket appeared torn, resulting in the inability to ensure a proper airtight seal of the lumens to the cvc.The lumens, gasket, and hub were therefore replaced with new components, resolving the issue." no reported patient harm.

• Brand Name: HEMODIALYSIS KIT: 2-L 15 FR X 27 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: marling heaton ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 24742278
• Report Number: 9680794-2026-00230
• Device Sequence Number: 12956729
• Product Code: MSD
• UDI-Device Identifier: 10801902154429
• UDI-Public: (01)10801902154429(11)250522(17)280430(10)33F25C0684(21)
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K141051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2026

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: IPN920484
• Device Catalogue Number: CS-15272-X
• Device Lot Number: 33F25C0684
• 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: 03/06/2026
• Supplement Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2025
• 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