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 IPN036438

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/11/2021

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).

Event Description

The complaint is reported as: the user tried to use the product and found that the echogenic needle would not draw up blood.The syringe did not have any resistance when pulling it back to draw.No patient injury or harm reported.The patient's condition is reported as fine.

Manufacturer Narrative

Qn# (b)(4).The customer returned one arrow raulerson syringe (ars) and introducer needle for evaluation.Visual examination did not reveal any anomalies or defects.The returned sample was functionally tested in accordance with the instructions-for-use provided with this kit.The ifu states, "insert introducer needle or catheter/needle with attached syringe or arrow raulerson syringe (where provided) into vein and aspirate." the ars was able to successfully aspirate water with and without the returned introducer needle attached (per amrq-000113 rev 3 req 6.1).No issues were identified.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 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.A device history record review was performed and no relevant findings were identified.The customer report of an ars leak was not confirmed by complaint investigation of the returned sample.The returned syringe was able to aspirate water through the returned introducer needle with no issues.The syringe also passed 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 Description

The complaint is reported as: the user tried to use the product and found that the echogenic needle would not draw up blood.The syringe did not have any resistance when pulling it back to draw.No patient injury or harm reported.The patient's condition is reported as fine.

• Brand Name: ARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8" (2
• Type of Device: CATHETER INTRAVASCULAR THERAP
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11557745
• MDR Text Key: 242070884
• Report Number: 9680794-2021-00126
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 10801902117189
• UDI-Public: 10801902117189
• Combination Product (y/n): N
• PMA/PMN Number: K071538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 03/11/2021

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
• Device Operator: No Information
• Device Expiration Date: 10/31/2022
• Device Model Number: IPN036438
• Device Catalogue Number: CDC-45703-P1A
• Device Lot Number: 13F20M0203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2021
• Initial Date Manufacturer Received: 03/11/2021
• Initial Date FDA Received: 03/23/2021
• Supplement Dates Manufacturer Received: 04/20/2021
• Supplement Dates FDA Received: 04/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1