MAUDE Adverse Event Report: 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 09/07/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The complaint is reported as: "there is air inside introduction syringe during suction." no patient harm reported.The device was replaced.The patient's condition is reported as fine.

Event Description

The complaint is reported as: "there is air inside introduction syringe during suction." no patient harm reported.The device was replaced.The patient's condition is reported as fine.

Manufacturer Narrative

Qn#(b)(4).The customer returned one arrow raulerson syringe (ars) and lidstock for investigation.Initial visual examination of the components did not reveal any anomalies or defects.After the ars failed functional testing (see below), the handle was broken to examine the valves inside.The valve mechanism consists of two bi-lateral valves and a spacer.Both valves were intact.However, the valve mechanism was found to be on an angle in the handle housing instead of perpendicular to the handle.The ifu provided with this kit states the following: "insert introducer needle or catheter/needle with attached syringe or arrow raulerson syringe (where provided) into vein and aspirate." the syringe was unable to successfully draw and aspirate water with a lab inventory introducer needle attached (per amrq-000113 rev 4 req 6.1).The module requirement document for raulerson syringes (amrq-000113 rev 4) 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 was 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 but did not snap back into a position = 1cc from the starting position.Therefore, the internal valve or the ars is not functioning as intended.A device history record review was performed with no relevant findings.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.Do not leave open needles or uncapped, unclamped catheters in central venous puncture site.Air embolus can occur with these practices.Do not reinsert needle into introducer catheter (where provided) to reduce risk of catheter embolus".The issue of the ars leaking was able to be confirmed by functional testing of the returned sample.The returned syringe was not able to draw water through a lab inventory introducer needle.The syringe was also not able to pass the vacuum test, indicating the valves of the syringe are not functioning as intended.When the handle was broken open the valves were found to be sitting at an angle within the handle instead of perpendicular to the handle.A device history record review was performed with no relevant findings.Based on the sample received, manufacturing cause or contributed this event.A non-conformance has been initiated to further investigate this issue.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 20 CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• MDR Report Key: 12576401
• MDR Text Key: 274734465
• Report Number: 3006425876-2021-00917
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K900263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 09/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 01/07/2023
• Device Catalogue Number: CS-25703-E
• Device Lot Number: 71F21B0643
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2021
• Date Manufacturer Received: 10/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2021
• 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