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

Catalog Number CV-17702-E

Device Problem Leak/Splash (1354)

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

Event Date 11/07/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that: 07 nov 2023, the ars was found to be leaking during used on the patient.Patient was reported as good post procedure.

Event Description

It was reported that: on (b)(6) 2023, the ars was found to be leaking during used on the patient.Patient was reported as good post procedure.

Manufacturer Narrative

(b)(4) the report of an ars leak was confirmed through complaint investigation of the returned sample.The customer returned one, opened cvc kit for analysis.No definite signs-of-use were observed on any of the returned components.Initial visual inspection of the arrow raulerson syringe (ars) did not reveal any anomalies or defects.After the ars failed functional testing, the plunger was removed.The plunger was then held up to a light such that the internal bivalves are visible.Visual inspection revealed that the valves contained a hole.The handle was then opened, and a hole was observed on the proximal valve.The returned sample was functionally tested with a lab inventory introducer needle per the instructions-for-use provided with this kit, "insert introducer needle with attached syringe or arrow raulerson syringe (where provided) into vein and aspirate".The ars successfully aspirated water and air with or without the returned introducer needle attached.The module requirement document for raulerson syringes was reviewed to determine r requirements for air/water leakage.The document notes 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 syringes 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 not snap back into a position within 1cc from the starting position.Therefore, the internal valves of the ars are not functioning as intended.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".A device history record review was performed, and no relevant findings were identified.Based on the customer report and the sample received, manufacturing caused or contributed to this event.Further investigation has been initiated under teleflex's quality system by the manufacturing site to further investigate this issue.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW CVC SET: 2-LUMEN 7 FR X 20 CM
• Type of Device: 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18244989
• MDR Text Key: 329441218
• Report Number: 3006425876-2023-01151
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801902105455
• UDI-Public: 00801902105455
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K862056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: CV-17702-E
• Device Lot Number: 71F22H3660
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2022
• 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