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 Codes	Obstruction of Flow (2423); Failure to Disconnect (2541); Separation Failure (2547)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that on (b)(6) 2026, during disconnection at the conclusion of a dialysis session, the inlet line of the cannon ii plus chdc (inserted on (b)(6) 2026) could not be removed despite multiple attempts by healthcare staff and the attending physician.It was observed that a non-teleflex connector had melted and fractured within the red catheter hub.Although the connector could be unscrewed, it rotated freely and could not be removed.As a precautionary measure, a second clamp was applied to the line using an applier.A temporary catheter was inserted into the left internal jugular vein in the intensive care unit.Subsequently, a replacement tunneled catheter was inserted into the right internal jugular vein on (b)(6) 2026.It was reported on (b)(6) 2026 that the patient had passed away; the death was reported as unrelated to this incident.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device 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 on 01apr2026, during disconnection at the conclusion of a dialysis session, the inlet line of the cannon ii plus chdc (inserted on (b)(6) 2026) could not be removed despite multiple attempts by healthcare staff and the attending physician.It was observed that a non-teleflex connector had melted and fractured within the red catheter hub.Although the connector could be unscrewed, it rotated freely and could not be removed.As a precautionary measure, a second clamp was applied to the line using an applier.A temporary catheter was inserted into the left internal jugular vein in the intensive care unit.Subsequently, a replacement tunneled catheter was inserted into the right internal jugular vein on (b)(6) 2026.It was reported on 10apr2026 that the patient had passed away; the death was reported as unrelated to this incident.

• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 25135609
• Report Number: 9680794-2026-00351
• Device Sequence Number: 15781928
• Product Code: MSD
• UDI-Device Identifier: 10801902154221
• UDI-Public: (01)10801902154221(11)250901(17)280731(10)33F25H0674(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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2026

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: IPN920489
• Device Catalogue Number: CS-15242-VSP
• Device Lot Number: 33F25H0674
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2026
• Supplement Date Received by Manufacturer: 06/01/2026
• Initial Report FDA Received Date: 05/11/2026
• Supplement Report FDA Received Date: 06/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2025
• 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 Age: 70 YR
• Patient Sex: Unknown