MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 7 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number CS-25703-E

Device Problem Gas/Air Leak (2946)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/27/2023

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

It was reported that the air was leaking from the syringe while being used on the patient.No patient injury was reported.

Manufacturer Narrative

(b)(4).The additional information received on 31jul2023 reported that the physician found out the leak while aspirating for blood during the procedure.Also, the customer pulled the plunger and found out that ars could not aspirate blood.An ultrasound was used to place the device and the venous access was confirmed.The insertion site used was neck and no medical intervention was required due to the event.The issue of ars leaking could not be confirmed during functional testing of the returned sample.The customer returned one arrow ra ulerson syringe (ars) and one 18 ga introducer needle for evaluation.Signs-of-use in the form of biological material were observed on the returned components.Visual examination of the ars and introducer needle did not reveal any anomalies or defects.The returned sample was functionally tested using the returned introducer needle in accordance with the instructions-for-use provided with this kit which states, "insert introducer needle or catheter/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, without any leaks or excessive air build-up.The module requirement document for raulerson syringes was reviewed to determine requirements for air/water leakage.The document noted a deviation from iso: "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 syringe 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 did snap back into a position = 1cc from the starting position.Therefore, the internal valves of the ars were functioning as intended.A device history record review was performed, and no relevant findings were identified.No problem was found with the returned device.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported that the air was leaking from the syringe while being used on the patient.No patient injury was reported.

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 20 CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 17389623
• MDR Text Key: 319962635
• Report Number: 9680794-2023-00540
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K900263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/04/2023

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 Operator: Health Professional
• Device Catalogue Number: CS-25703-E
• Device Lot Number: 71F22K2463
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/04/2023
• Initial Date FDA Received: 07/25/2023
• Supplement Dates Manufacturer Received: 08/23/2023
• Supplement Dates FDA Received: 08/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: NOT REPORTED; NOT REPORTED