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 Codes	Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "when the swg inserted into the ars, the doctor found resistance, the swg kinked during use on the patient." the user changed to a new set to successfully complete the procedure.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
Qn#(b)(4).
Additional Manufacturer Narrative
(b)(4).The customer returned multiple components of a hemodialysis kit, including one catheter and dilator, for analysis.The arrow raulerson syringe (ars) and guide wire assembly were not returned for analysis.No signs of use were observed on the components.Visual inspection could not be per-formed as the guide wire and ars were not returned for analysis.Dimensional, functional inspections could not be performed as the guide wire and ars were not returned for analysis.A device his-tory record review was performed, and no relevant findings were identified.The customer report of a kinked guide wire could not be confirmed through investigation of the returned sample.The customer did not return the guide wire or ars for analysis, so inspections could not be performed on the re-ported components.Therefore, based on the customer report and the sample received, the potential root cause cannot be determined at this time.Teleflex will continue to monitor and trend on reports of this nature.Corrected data: section d.4.Unique identifier (udi)# corrected to (b)(4).
Event or Problem Description
It was reported that "when the swg inserted into the ars, the doctor found resistance, the swg kinked during use on the patient." the user changed to a new set to successfully complete the procedure.No medical intervention required.The patient's current condition is reported as "fine".

• 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: 19444838
• Report Number: 3006425876-2024-00537
• Device Sequence Number: 16947479
• Product Code: MPB
• UDI-Device Identifier: 00801902100252
• UDI-Public: 00801902100252
• 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): 05/07/2024

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: 03/27/2025
• Device Catalogue Number: CU-22122-F
• Device Lot Number: 71F23D0178
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2024
• Supplement Date Received by Manufacturer: 06/07/2024
• Initial Report FDA Received Date: 06/02/2024
• Supplement Report FDA Received Date: 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2023
• 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: NONE REPORTED.; NONE REPORTED.
• Patient Sex: Unknown