MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 5 FR X 20 CM; CATHETER PERCUTANEOUS

Catalog Number	ES-04301
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "the doctor found the ars leak during use on the patient".They changed a new one to resolve the issue.No harm for the patient.The patient condition is fine.No medical intervention was required.
Additional Manufacturer Narrative
(b)(4).The customer returned one arrow raulerson syringe (ars), arrow advancer, 18ga introducer needle, transduction probe, dilator, and catheter for analysis.Signs of use were observed inside the ars.Visual inspection of the ars did not reveal any anomalies or defects.The returned sample was functionally tested with the returned introducer needle per the instructions for use provided with this kit.The ifu states, "insert introducer needle with attached syringe or arrow raulerson syringe (where provided) into vein and aspirate".The ars was able to draw and aspirate water with and without the introducer needle attached.No leaks or excessive air buildup was observed.The module requirement document for raulerson syringe (amrq-000113 rev03) 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." a vacuum test was performed on the ars in order to verify that the internal valves within the plunger body were intact.With the plunger body at the bottom of the syringe, the tip of the ars was occluded, and the plunger was pulled back until it stopped.With the tip of the ars still occluded, the plunger was released and snapped back into a position = 1cc from the starting position.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit warns the user, "warning: do not aspirate arrow raulerson syringe while guidewire is in place; air may enter syringe through rear valve." the customer report of a leaking ars could not be confirmed through investigation of the returned sample.Functional testing of the returned ars revealed no obvious defects or anomalies.The ars was able to draw and aspirate water with and without the returned introducer needle and passed all relevant additional testing.Therefore, based on the sample received and the customer report, no problem was found with the returned device.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "the doctor found the ars leak during use on the patient".They changed a new one to resolve the issue.No harm for the patient.The patient condition is fine.No medical intervention was required.

• Brand Name: ARROW CVC SET: 5 FR X 20 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21079758
• Report Number: 3006425876-2025-00027
• Device Sequence Number: 8322752
• Product Code: DQY
• UDI-Device Identifier: 10801902122756
• UDI-Public: (01)10801902122756(11)230221(17)280131(10)71F23B1134(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
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2024

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 Catalogue Number: ES-04301
• Device Lot Number: 71F23B1134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2024
• Supplement Date Received by Manufacturer: 01/14/2025
• Initial Report FDA Received Date: 01/06/2025
• Supplement Report FDA Received Date: 01/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2023
• 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