MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 7 FR X 30 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number CS-24703-E

Device Problem Infusion or Flow Problem (2964)

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

Event Date 04/01/2021

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

The complaint is reported as: "the blue tube inside introduction syringe was falling out when pulling" and the ars syringe was unable to withdraw blood.A new syringe was used.No patient harm reported.The patient's condition is reported as fine.

Event Description

The complaint is reported as: "the blue tube inside introduction syringe was falling out when pulling" and the ars syringe was unable to withdraw blood.A new syringe was used.No patient harm reported.The patient's condition is reported as fine.

Manufacturer Narrative

Qn#(b)(4).The customer returned one arrow raulerson syringe (ars) for evaluation.Visual examination of the ars did not reveal any anomalies or defects.After the ars failed the vacuum leak functional test , 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.The ifu provided with this kit states: "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 3 req 6.1).When drawing water, bubbles were observed in the base of the syringe.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 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 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.R & d and manufacturing were consulted as part of this complaint.They indicated that the likely failure mode is that the valve mechanism was found to be on an angle in the handle housing instead of perpendicular to the handle.A device history record review was performed, and no relevant findings were identified.The ifu provided with this kit states: "insert introducer needle or catheter/needle with attached syringe or arrow raulerson syringe (where provided) into vein and aspirate." the issue of the ars leaking was able to be confirmed by functional testing of the returned sample.When drawing water, bubbles were observed in the base of the syringe.The syringe was also not able to pass the vacuum test, indicating the valves of the syringe are not functioning as intended.R & d and manufacturing were consulted as part of this complaint.They indicated that the likely failure mode is that the valve mechanism was found to be on an angle in the handle housing instead of perpendicular to the handle.A device history record review was performed, and no relevant findings were identified.Based on the sample received, manufacturing cause or contributed this event.A non-conformance has been initiated to further investigate this issue.

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 30 CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11736872
• MDR Text Key: 247731386
• Report Number: 3006425876-2021-00356
• 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: 04/07/2021

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: 08/25/2022
• Device Catalogue Number: CS-24703-E
• Device Lot Number: 71F20J1354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2021
• Initial Date Manufacturer Received: 04/07/2021
• Initial Date FDA Received: 04/28/2021
• Supplement Dates Manufacturer Received: 05/27/2021
• Supplement Dates FDA Received: 05/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1