MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 7 FR X 16 CM; CATHETER PERCUTANEOUS

Model Number	IPN030855
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The complaint is reported as: happened in the room of the patient in resuscitation department.Involved a hypotensive patient requiring the insertion of a cvc in left internal jugular with injection of noradrenaline on the tri-lumen cvc.There was a rapid increase of the noradrenaline (up to 15 mgr/h or speed 30 cc/h, which is a very very high dose) but with no beneficial effect for the patient.The team decided to insert a second central venous catheter in the right femoral.There was an increase of the pressure on this new cvc (the one inserted in femoral) because of the injection of norepinephrine.The patient was treated, but there was a waste of time to insert the second device.
Additional Manufacturer Narrative
(b)(4).The customer returned one, three-lumen cvc for analysis.Signs-of-use in the form of biological material was observed inside the medial extension line.Visual analysis did not reveal any obvious defects or anomalies.The catheter body length from the juncture hub to the distal tip measured 168mm which is within the specification limits of 157mm-177mm per the catheter graphic.The catheter body outer diameter measured 2.46mm which is within the specification limits of 2.39mm-2.49mm per the catheter extrusion graphic.The returned catheter was initially flushed to ensure no blockages were present.The distal end of the catheter body was then clamped, and each line was pressurized using a water-filled lab inventory syringe.No leaks or blockages were detected.The returned catheter was then tested per bs en iso 10555-1 section 4.7.1 (amrq-000071) which states that there shall be no liquid leakage in the form of one or more falling drops when pressurized to 300 kpa for 30 seconds.The catheter was connected to lab leak tester and pressurized to 300 kpa for 30 seconds.No leaks were observed from any region of the catheter.A device history record review was performed based on the potential lot number provided by the customer and no relevant findings were identified.The ifu provided with this kit warns the user, "air embolism can occur if air is allowed to enter a central venous access device or vein.Do not leave open needles or uncapped, unclamped catheters in central venous puncture site.Use only securely tightened luer-lock connections with any central venous access device to guard against inadvertent disconnection." the customer report of patient/user complication was not able to be confirmed through complaint investigation of the returned sample.No defects or anomalies were observed with the returned catheter.Additionally, the catheter met all relevant dimensional and functional requirements, and a device history record review was performed based on the potential lot supplied by the customer and no relevant findings were identified.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
The complaint is reported as: happened in the room of the patient in rescucitation department.Involved a hypotensive patient requiring the insertion of a cvc in left internal jugular with injection of noradrenaline on the tri-lumen cvc.There was a rapid increase of the noradrenaline (up to 15 mgr / h or speed 30 cc / h, which is a very very high dose) but with no beneficial effect for the patient.The team decided to insert a second central venous catheter in the right femoral.There was an increase of the pressure on this new cvc (the one inserted in femoral) because of the injection of norepinephrine.The patient was treated, but there was a waste of time to insert the second device.

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 16 CM
• Common Device Name: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 12555899
• Report Number: 3006425876-2021-00889
• Device Sequence Number: 14508326
• Product Code: DQY
• UDI-Device Identifier: 10801902105223
• UDI-Public: 10801902105223
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K862056
• 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): 09/08/2021

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 Model Number: IPN030855
• Device Catalogue Number: CV-12703
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2021
• Initial Date Received by Manufacturer: 09/08/2021
• Supplement Date Received by Manufacturer: 10/22/2021
• Initial Report FDA Received Date: 09/30/2021
• Supplement Report FDA Received Date: 10/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NORADRENALINE; NORADRENALINE; NORADRENALINE