MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PSI KIT: 8.5 FR; INTRODUCER CATHETER

Model Number	IPN036824
Medical Device Problem Code	Suction Failure (4039)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "the introducer needle was defective and did not form vacuum".The device was replaced and procedure completed.No patient harm reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).The customer returned one arrow raulerson syringe (ars), two catheter/needle assemblies, and one spring wire guide for evaluation.Initial visual examination of the components did not reveal any anomalies or defects.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.Both valves were intact and their slits were present.However, the valve mechanism was found to be on an angle in the handle housing instead of perpendicular to the handle.The syringe was not able to successfully draw and aspirate water with both returned catheter/needle assemblies attached.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 seal 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 valves of the ars are not functioning as intended.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 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.Based on the sample received, manufacturing cause or contributed this event.A non-conformance has been initiated to further investigate this issue.
Event or Problem Description
It was reported "the introducer needle was defective and did not form vacuum".The device was replaced and procedure completed.No patient harm reported.The patient's condition is reported as fine.

• Brand Name: ARROW PSI KIT: 8.5 FR
• Common Device Name: INTRODUCER CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11709955
• Report Number: 9680794-2021-00166
• Device Sequence Number: 14237471
• Product Code: DYB
• UDI-Device Identifier: 20801902121756
• UDI-Public: 20801902121756
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K780532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2021

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
• Operator of Device: Health Professional
• Device Model Number: IPN036824
• Device Catalogue Number: AK-09803-CDC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2021
• Initial Date Received by Manufacturer: 04/01/2021
• Supplement Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 04/22/2021
• Supplement Report FDA Received Date: 05/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1