MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 8FR X 20CM; CATHETER,INTRAVASCULAR,THERAP

Model Number	IPN914894
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Customer reported that "puncture needle aspirated air".No patient harm or injury reported.A new kit was obtained for use.
Additional Manufacturer Narrative
(b)(4).The customer returned one arrow raulerson syringe (ars) and one introducer needle for analysis.Signs-of use was observed on the needle cannula.Visual examination of the ars and introducer needle did not reveal any anomalies or defects.The module requirement document for raulerson syringes 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 and snapped back into a position = 1cc from the starting position.Therefore, the internal valves of the ars are functioning as intended.A device history record review was performed, and no relevant findings were identified.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 the returned 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.A device history record review did not reveal any relevant findings.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 reported that "puncture needle aspirated air".No patient harm or injury reported.A new kit was obtained for use.

• Brand Name: ARROW CVC SET: 2-LUMEN 8FR X 20CM
• Common Device Name: CATHETER,INTRAVASCULAR,THERAP
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11382798
• Report Number: 3006425876-2021-00171
• Device Sequence Number: 14049549
• Product Code: FOZ
• UDI-Device Identifier: 10801902159349
• UDI-Public: 10801902159349
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K900263
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2021

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: 06/25/2022
• Device Model Number: IPN914894
• Device Catalogue Number: CV-25802-E
• Device Lot Number: 71F20G1405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2021
• Initial Date Received by Manufacturer: 02/10/2021
• Supplement Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 02/25/2021
• Supplement Report FDA Received Date: 03/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1