MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 7 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number CS-27702-E

Device Problem Fluid/Blood Leak (1250)

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

Event Date 01/09/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Associated mdr#s: 3006425876-2023-00183; 3006425876-2023-00184; 3006425876-2023-00185; and 3006425876-2023-00182.

Event Description

It was reported the luer/hub fitting connection was found leaking during use on the patient.The alleged issue occurred with 5 devices on the same patient during the same event.No patient harm was reported.The patient's condition is reported as fine.Additional information was requested but was not available at the time of this report.

Manufacturer Narrative

(b)(4).Associated mdr#s: 3006425876-2023-00183; 3006425876-2023-00184; 3006425876-2023-00185; 3006425876-2023-00186; 3006425876-2023-00182.The customer returned an opened cvc kit containing multiple components , including one arrow raulerson syringe (ars), an introducer needle, a guide wire assembly, and the product lidstock for analysis.Signs of use in the form of biological material were observed on the ars.Visual examination of the ars did not reveal any obvious defects or anomalies.The syringe was able to successfully draw and aspirate water with and without the returned introducer needle attached (per amrq-000113 rev 3 req 6.1).The module requirement document for raulerson syringes (amrq-000113 rev 3) 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 syringes (reference pip-078 rev 5) 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 did snap back into a position = 1cc from the starting position.Therefore, the internal valves of the ars are functioning as intended.A device history record review was performed, and no relevant findings were identified.The customer report of the ars leaking was not able to be confirmed by functional testing of the returned sample.The returned syringe was able to draw and aspirate water through the returned introducer needle with no issues.The syringe was also able to pass the vacuum test, indicating the valves of the syringe are functioning as intended.Based on the sample received and complaint investigation, no problem was found on the device.Teleflex will continue to monitor and trend reports of this nature.

Event Description

It was reported the luer/hub fitting connection was found leaking during use on the patient.The alleged issue occurred with 5 devices on the same patient during the same event.No patient harm was reported.The patient's condition is reported as fine.Additional information was requested but was not available at the time of this report.

• Brand Name: ARROW CVC SET: 2-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 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: 16305180
• MDR Text Key: 308877742
• Report Number: 3006425876-2023-00186
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 01/10/2023

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 Expiration Date: 02/17/2024
• Device Catalogue Number: CS-27702-E
• Device Lot Number: 71F22C0246
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/10/2023
• Initial Date FDA Received: 02/06/2023
• Supplement Dates Manufacturer Received: 02/27/2023
• Supplement Dates FDA Received: 02/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NOT REPORTED; NOT REPORTED