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

Model Number	IPN920516
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/30/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "wear and tear evident to end of arterial lumen from connection/disconnection to haemodialysis.Bleep from connection point within 3 minutes of commencing haemodialysis.".
Additional Manufacturer Narrative
Qn# (b)(4).The reported issue of arterial hub damage was confirmed through review of customer supplied pictures.No unit was returned for evaluation.A picture was provided confirming damage to the arterial section of the hub.Signs of use were observed.Scratches and marks were noted on the hub.The full extent and degree of damage could not be confirmed without a returned product.A dhr review was completed and no non-conformities related to the issue were observed.It is unknown if excessive force or tools were used on the hubs for connection/disconnection at the hub.The ifu was reviewed and the following was noted: - avoid clamping near luer-lock fittings.- repeated over tightening of bloodlines, syringes and caps will reduce connector life and could lead to potential connector failure.Based on the report and without a sample returned, the most likely root cause is undeterminable.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: "wear and tear evident to end of arterial lumen from connection/disconnection to haemodialysis.Bleep from connection point within 3 minutes of commencing haemodialysis.".

• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 24504952
• Report Number: 9680794-2026-00165
• Device Sequence Number: 9960077
• Product Code: MSD
• UDI-Device Identifier: 00801902096296
• UDI-Public: (01)00801902096296(11)230707(17)260630(10)33F23E0576(21)
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K111900
• 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): 02/10/2026

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 Expiration Date: 06/30/2026
• Device Model Number: IPN920516
• Device Catalogue Number: CS-15232-SFX
• Device Lot Number: 33F23E0576
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2026
• Supplement Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2023
• 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