MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM; CATHETER HEMODIALYTSIS NON IMP

Model Number	IPN038320
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported the ars syringe was found leaking during patient puncture.No patient harm reported.The patient's condition is reported as fine.
Event or Problem Description
It was reported the ars syringe was found leaking during patient puncture.No patient harm reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned multiple components from an acute hemodialysis kit.The arrow raulerson syringe (ars) will be analyzed as part of this complaint investigation.No definite signs-of-use were observed.After failing functional testing, the handle was broken to examine the valves inside.The valve mechanism should consist of two bi-lateral valves and a spacer.Visual analysis revealed that only one valve was present.The second valve and the spacer were missing from the assembly.The returned sample was functionally tested in accordance with the instructions-for-use (ifu) provided with this kit.The ifu instructs the user, "insert introducer needle with attached arrow raulerson syringe into vein and aspirate." the syringe was attached to a lab inventory syringe but was unable to successfully draw and aspirate water.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 valves of the ars are not functioning as intended.A device history record review was performed, and no relevant findings were identified.The ifu provided with this kit states the following: "insert introducer needle with attached arrow raulerson syringe into vein and aspirate." the report of a leaking ars was confirmed through complaint investigation.Visual and functional analysis revealed that one of the two bi-lateral valves and the spacer were missing from the assembly.A device history record review did not reveal any relevant findings.Based on the customer report and the sample received, manufacturing (assembly) caused or contributed to this event.A non-conformance was initiated to further investigate this complaint issue.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM
• Common Device Name: CATHETER HEMODIALYTSIS NON IMP
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 12348593
• Report Number: 3006425876-2021-00772
• Device Sequence Number: 5189801
• Product Code: MPB
• UDI-Device Identifier: 10801902139204
• UDI-Public: 10801902139204
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K993933
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2021

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: No Information
• Device Expiration Date: 06/16/2022
• Device Model Number: IPN038320
• Device Catalogue Number: CS-25122-F
• Device Lot Number: 71F20H1643
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2021
• Initial Date Received by Manufacturer: 08/05/2021
• Supplement Date Received by Manufacturer: 09/24/2021
• Initial Report FDA Received Date: 08/20/2021
• Supplement Report FDA Received Date: 09/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1