MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC/PSI KIT: 3-L 7FR X 16CM/8.5FR X 10CM; CATHETER,INTRAVASCULAR,THERAPE

Catalog Number ASK-42703-PSI1

Device Problems Decrease in Suction (1146); Gas/Air Leak (2946)

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

Event Date 11/16/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The complaint is reported as: "raulerson syringe - the plunger is not giving any resistance, slid too easy.Was not able to generate the negative pressure to aspirate blood into the syringe." no patient harm reported.The patient's condition is reported as fine.A new syringe was used.

Manufacturer Narrative

(b)(4).The customer returned one arrow raulerson syringe (ars) for analysis.Signs of use in the form of biological material were observed on the ars.Visual examination of the ars did not reveal any anomalies or defects.The returned sample was functionally tested using a lab inventory introducer needle in accordance with the instructions for use provided with this kit.The ifu states, "insert introducer needle or catheter/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, without any leaks or excessive air buildup.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 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 snap back into a position = 1cc from the starting position.Therefore, the internal valves of the ars are functioning as intended.A device history record review was performed, and no relevant findings were identified.The issue of ars leaking could not be confirmed during functional testing of the returned sample.The ars was able to draw and aspirate water with and without an introducer needle, and passed all relevant additional testing.No problem was found with the returned device.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The complaint is reported as: "raulerson syringe - the plunger is not giving any resistance, slid too easy.Was not able to generate the negative pressure to aspirate blood into the syringe." no patient harm reported.The patient's condition is reported as fine.A new syringe was used.

• Brand Name: ARROW CVC/PSI KIT: 3-L 7FR X 16CM/8.5FR X 10CM
• Type of Device: CATHETER,INTRAVASCULAR,THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 13018865
• MDR Text Key: 282345709
• Report Number: 9680794-2021-00669
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K071538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: ASK-42703-PSI1
• Device Lot Number: 13F21E0035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2021
• 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