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 12/01/2023

Event Type  malfunction  

Event Description

It was reported that: 01 dec 2023, the ars was found to be leaking during used on the patient.The patient was reported as fine psot the procdure.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Qn# (b)(4).The customer report of a leaking ars was not able to be confirmed by complaint investigation of the returned sample.The customer provided two photos showing the arrow raulerson syringe (ars), introducer needle, and lidstock and returned one, opened cvc for analysis.Visual inspection of the ars did not reveal any anomalies or defects.Analysis of the introducer needle revealed slight bending on the cannula located adjacent to the needle hub.The returned sample was functionally tested with the returned 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 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 was reviewed to determine 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 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 less than or equal to 1cc from the starting position.Therefore, the internal valves of the ars were 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.The returned ars showed no visual or functional anomalies.Based on the customer report and the sample received, no problem was found with the returned sample.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported that: on (b)(6) 2023, the ars was found to be leaking during used on the patient.The patient was reported as fine psot the procdure.

• 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: 18397223
• MDR Text Key: 331500910
• Report Number: 3006425876-2023-01279
• 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: 12/01/2023

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 Catalogue Number: CV-17702-E
• Device Lot Number: 71F22H1868
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/01/2023
• Initial Date FDA Received: 12/27/2023
• Supplement Dates Manufacturer Received: 02/01/2024
• Supplement Dates FDA Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2022
• 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.