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 Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "on (b)(6) 2024, prior to catheterization, teacher from the emergency department identified the swg kinked.No patient involved.".
Event or Problem Description
It was reported that: "(b)(6) 2024, prior to catheterization, teacher from the emergency department identified the swg kinked.No patient involved.".
Additional Manufacturer Narrative
(b)(4).The report of a damaged guidewire was confirmed through complaint investigation of the returned sample.The customer returned one opened hemodialysis set including a guidewire inside the advancer assembly, arrow raulerson syringe, transduction probe, 2-lumen catheter, scalpel, dilator, catheter-over-needle, and introducer needle for analysis.No signs of use were observed.Visual analysis revealed offset coils on the j-bend of the guidewire.The guidewire met all relevant dimensional and functional requirements.A device history record review did not reveal any relevant findings.Because the damage was observed in areas where the product would have been protected in the packaging, the time of the damage cannot be confirmed.Due to these circumstances, the root cause of this event cannot be determined at this time.Teleflex will continue to monitor and trend for complaints of this nature.

• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 24092833
• Report Number: 3006425876-2026-00124
• Device Sequence Number: 21414624
• Product Code: MPB
• UDI-Device Identifier: 00801902100252
• UDI-Public: (01)00801902100252(11)230123(17)241128(10)71F23A1287(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): 12/26/2025

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 Expiration Date: 11/28/2024
• Device Catalogue Number: CU-22122-F
• Device Lot Number: 71F23A1287
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2025
• Supplement Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 01/16/2026
• Supplement Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2023
• 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: N/A.; N/A.
• Patient Sex: Unknown