MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8" (2; CATHETER INTRAVASCULAR THERAP

Model Number	IPN036445
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Customer reports when initially inserting the entry needle/catheter and pulling back for blood to confirm placement they are getting a flash or blood and then just air.Customer reports they confirmed they are in the artery via ultrasound and are only getting blood return when they disconnect the syringe.No patient harm reported.
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one cvc kit containing various components including an ars; no introducer needle was returned.Visual examination of the ars and other components did not reveal any anomalies or defects.The syringe was able to successfully draw and aspirate water with a lab inventory introducer needle attached (per (b)(4) rev 3 req 6.1).No issues were identified.The module requirement document for raulerson syringes ((b)(4) rev 3) was reviewed to determine requirements for air/water leakage.The document notes a deviation from iso (b)(4): "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 snapped back into a position = 1cc from the starting position.Therefore, the internal valves of the ars are functioning as intended.The instructions for use (ifu) warns the user, "aspiration with spring-wire guide in place will cause introduction of air into arrow raulerson syringe." the issue of the ars leaking was not able to be confirmed by functional testing of the returned sample.The returned syringe was able to draw and aspirate water through a lab inventory introducer needle with no issues.The syringe was also able to pass the vacuum test, indicating the valves of the syringe are functioning as intended.Based on the sample received, no problem was found on the device.Teleflex will continue to monitor and trend reports of this nature.
Event or Problem Description
Customer reports when initially inserting the entry needle/catheter and pulling back for blood to confirm placement they are getting a flash or blood and then just air.Customer reports they confirmed they are in the artery via ultrasound and are only getting blood return when they disconnect the syringe.No patient harm reported.

• Brand Name: ARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8" (2
• Common Device Name: CATHETER INTRAVASCULAR THERAP
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11853032
• Report Number: 9680794-2021-00232
• Device Sequence Number: 17111027
• Product Code: FOZ
• UDI-Device Identifier: 10801902116793
• UDI-Public: 10801902116793
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K071538
• 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): 04/29/2021

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: 12/31/2022
• Device Model Number: IPN036445
• Device Catalogue Number: CDC-15703-P1A
• Device Lot Number: 13F21A0066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2021
• Initial Date Received by Manufacturer: 04/29/2021
• Supplement Date Received by Manufacturer: 06/15/2021
• Initial Report FDA Received Date: 05/19/2021
• Supplement Report FDA Received Date: 06/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1