MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 16 CM; CATHETER HEMODIALYSIS NON IMPL

Catalog Number	CU-22122-F
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "(b)(6) 2026, the needle cannual separated from hub during used on the patient.No harm for the patient.The patient condition is fine.No medical intervention was required.They changed a new one to resolve the issue.".
Additional Manufacturer Narrative
(b)(4).The customer provided one video for analysis; the complaint of a cannula separating from the hub was confirmed.Signs-of-use were observed inside the sample, which confirms the report that the defect was observed during use.A device history record review was performed, and no relevant findings were identified.The report that a needle cannula separated from the hub was confirmed through analysis of the customer supplied video.A device history record review was performed and did not reveal any relevant findings.Based on the customer report, the supplied video, and the comments from manufacturing, the likely root cause is manufacturing related.Non-conformance was initiated to further investigate this complaint.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: "on (b)(6) 2026, the needle cannual separated from hub during used on the patient.No harm for the patient.The patient condition is fine.No medical intervention was required.They changed a new one to resolve the issue.".

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 16 CM
• Common Device Name: CATHETER HEMODIALYSIS NON IMPL
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 24363077
• Report Number: 3006425876-2026-00189
• Device Sequence Number: 4749872
• Product Code: MPB
• UDI-Device Identifier: 00801902100252
• UDI-Public: (01)00801902100252(11)250414(17)270212(10)71F25D0516(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K993933
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2026

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 Catalogue Number: CU-22122-F
• Device Lot Number: 71F25D0516
• 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: 01/22/2026
• Supplement Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2025
• 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