MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC 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 03/18/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that: " on (b)(6) 2024, the doctor found the ars to be leaking prior to the patient.

Manufacturer Narrative

(b)(4).The customer returned multiple components of a cvc kit, including one arrow raulerson syringe (ars) and introducer needle, for analysis.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 (ifu) 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.No leaks or excessive air buildup was observed.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." a vacuum test was performed on the ars syringe 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.Therefore, the internal valves of the ars were functioning as intended.A 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 customer report of an ars leaking 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 an introducer needle and passed all relevant additional testing.Therefore, based on the sample received, 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: "(b)(6) 2024, the doctor found the ars to be leaking prior to the patient.Further clarification received indicates the issue was detected during use on a patient.The condition of the patient was reported as "fine".

• Brand Name: 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: 19211356
• MDR Text Key: 341356904
• Report Number: 3006425876-2024-00461
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801902102362
• UDI-Public: 00801902102362
• 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,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/17/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: CS-27702-E
• Device Lot Number: 71F22H2410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2024
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/17/2024
• Initial Date FDA Received: 04/30/2024
• Supplement Dates Manufacturer Received: 05/01/2024
• Supplement Dates FDA Received: 05/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2022
• 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.