MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 7 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number CS-25703-E

Device Problem Infusion or Flow Problem (2964)

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

Event Date 03/30/2021

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

It was reported the introducer needle does not have suction during use.The device was replaced.No patient harm reported.The patient's condition is reported as fine.

Event Description

It was reported the introducer needle does not have suction during use.The device was replaced.No patient harm reported.The patient's condition is reported as fine.

Manufacturer Narrative

Qn#(b)(4).The customer returned one opened cvc kit containing various components including an ars for evaluation.Initial visual analysis did not reveal any defects or anomalies.After the ars failed functional testing, the handle was broken to examine the valves inside.The valve mechanism consists of two bi-lateral valves and a spacer.A small puncture hole was observed in the both the distal and proximal valves.Slits were present in both valves.The syringe was unable to successfully draw and aspirate water with a lab inventory 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 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, 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.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 confirmed during functional testing of the returned sample.The returned syringe failed the vacuum test.Further examination of the valves revealed a small puncture hole in both of the valves.A device history record review did not reveal any relevant findings.A capa has been initiated to further investigate this complaint issue; corrective actions have not yet been implemented.Teleflex will continue to monitor and trend reports of this nature.

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 20 CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11699824
• MDR Text Key: 246474172
• Report Number: 3006425876-2021-00348
• 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: 03/30/2021

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: No Information
• Device Expiration Date: 09/08/2022
• Device Catalogue Number: CS-25703-E
• Device Lot Number: 71F20J1022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2021
• Initial Date Manufacturer Received: 03/30/2021
• Initial Date FDA Received: 04/21/2021
• Supplement Dates Manufacturer Received: 05/18/2021
• Supplement Dates FDA Received: 05/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1