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

Catalog Number	CS-12122-F
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that"(b)(6) 2023, the ars was found leak during used on the patient.The patient was reported as fine.
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported that"(b)(6) 2023, the ars was found leak during used on the patient.The patient was reported as fine.
Additional Manufacturer Narrative
(b)(4).The customer returned one guide wire assembly, one dilator, and one catheter over needle for analysis.Signs of use in the form of biological material were observed on the guide wire.It was noted that the arrow raulerson syringe (ars) nor the 18ga introducer needle involved with this complaint were returned for analysis.Visual inspection of the ars and introducer needle could not be performed as they were not returned for analysis.It was noted that the guide wire body was kinked.The customer was contacted to address this discrepancy, and they confirmed that they do not want to report on the kinked guide wire.Therefore, the circumstances why the guide wire was kinked cannot be verified.The module requirement document for raulerson syringes (amrq-000113 rev.03) was reviewed to determine requirements for air/water leakage.The document notes a deviation from iso 7886-1: "the freedom of air and liquid leakage past the piston requirement is design restrictive and is intended for an injection-intended syringe, not the ars.The opening in the center of the piston that allows passage of the inner cannula prohibits the ars from meeting the pressure and vacuum requirements as dictated by the standard.However, because the intended use of the ars is to allow aspiration of blood to ensure venous placement of the introducer needle and to aid in the insertion of the spring wire guide, the leakage requirements of a standard syringe are not applicable to the ars." despite this, additional testing cannot be performed on the ars as it was not returned for analysis.Device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "insert introducer needle or catheter/needle with attached syringe or arrow raulerson syringe (where provided) into vein and aspirate".The issue of ars leaking could not be confirmed as part of this complaint investigation.Visual and functional analyses could not be performed as neither the ars nor the introducer needle were returned for analysis.A device history record review was performed, and no relevant findings were identified.Based on the customer report and the sample received, the root cause cannot be determined at this time.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that"on (b)(6) 2023, the ars was found leak during used on the patient.The patient was reported as fine.
Additional Manufacturer Narrative
(b)(4).In section d provided the full udi # udi related data quality updates only.

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 16 CM
• Common Device Name: CATHETER PERCUTANEOUS
• 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: marling heaton ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18299837
• Report Number: 3006425876-2023-01217
• Device Sequence Number: 15199512
• Product Code: DQY
• UDI-Device Identifier: 00801902100108
• UDI-Public: (01)00801902100108(11)220816(17)270731(10)71F22H1708(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/14/2023

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
• Device Catalogue Number: CS-12122-F
• Device Lot Number: 71F22H1708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2023
• Supplement Date Received by Manufacturer: 01/03/2024; Not provided
• Initial Report FDA Received Date: 12/11/2023
• Supplement Report FDA Received Date: 01/04/2024; 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2022
• 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; NOT REPORTED
• Patient Sex: Unknown