MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 7 FR X 16 CM; CATHETER INTRAVASCULAR THERAPE

Model Number	IPN030123
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Customer reported difficulty aspirating blood, leakage of blood from syringe, and needle hub leakage.A new kit was used.No patient harm was reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
Qn#(b)(4).The customer report of a leaking ars could not be confirmed by visual inspection of the customer supplied photo.Additionally, full complaint verification testing could not be performed as no sample was returned for analysis.The instructions for use (ifu) provided with this kit warns the user, "warning: do not aspirate arrow raulerson syringe while guidewire is in place; air may enter syringe through rear valve." a device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
Customer reported difficulty aspirating blood, leakage of blood from syringe, and needle hub leakage.A new kit was used.No patient harm was reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(6) the customer returned one, opened cvc for analysis.The ars will be analyzed as part of this complaint investigation.Visual inspection of the ars did not reveal any anomalies or defects.Analysis of the introducer needle could not be performed as it was not returned.The returned sample was functionally tested with a lab inventory introducer needle per the instructions for use provided with this kit.The ifu states, "insert introducer 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.No leaks or excessive air buildup was observed.The module requirement document for raulerson syringes (amrq-000113 rev.03) 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 and did snap back into a position = 1cc from the starting position.Therefore, the internal valves of the ars were 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".The customer report of a leaking ars was not able to be confirmed by complaint investigation.The returned ars showed no visual or functional anomalies, and a device history record review did not reveal any relevant findings.Based on the customer report and the sample received, no problem was found with the returned sample.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
Customer reported difficulty aspirating blood, leakage of blood from syringe, and needle hub leakage.A new kit was used.No patient harm was reported.The patient's condition is reported as fine.

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 16 CM
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17288815
• Report Number: 3006425876-2023-00647
• Device Sequence Number: 17806968
• Product Code: FOZ
• UDI-Device Identifier: 00801902102218
• UDI-Public: 00801902102218
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K900263
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/13/2023

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 Expiration Date: 05/31/2024
• Device Model Number: IPN030123
• Device Catalogue Number: CS-22703-E
• Device Lot Number: 71F22E1288
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2023
• Supplement Date Received by Manufacturer: 08/01/2023; 03/05/2024
• Initial Report FDA Received Date: 07/10/2023
• Supplement Report FDA Received Date: 08/03/2023; 03/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown