MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC KIT: 4-LUMEN 8.5FR X 16CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number CS-42854-HP

Device Problem Improper Flow or Infusion (2954)

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

Event Date 02/17/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The complaint is reported as: cvc inserted on (b)(6) 2022 by anesthetist.On (b)(6) 2022, on aspiration of the grey lumen which was infusing noradrenaline, propofol was aspirated as well as or instead of noradrenaline in icu.Cvc removed as planned.No patient harm reported.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4).The customer returned one 4-lumen cvc for analysis.Signs of use in the form of biological material was observed on the catheter body and in the extension lines.Visual analysis of the returned catheter did not reveal any defects or anomalies.The catheter body length from the juncture hub to the distal tip measured 168 mm which is within the specification limits of 157-177 mm per the catheter graphic.The catheter body outer diameter measured 2.92 mm which is within the specification limits of 2.87-2.97 mm per the catheter extrusion graphic.Functional inspection was performed per the instructions-for-use (ifu) provided with this kit.The ifu states, "check lumen patency by attaching a syringe to each extension line and aspirate until free flow of venous blood is observed".All four lumens of the returned catheter were flushed with a lab inventory syringe filled with water.No blockages or leaks were encountered as fluid passed through the respective skive holes/exit points for all four extension lines.The returned catheter was 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.With the distal end of the catheter occluded, each catheter extension line was individually connected to lab leak tester and pressurized to 300 kpa for 30 seconds.No backflow, leaks or evidence of a breach in any of the 4 lumens were observed.A lab inventory guide wire of the same size as the guide wire provided with this kit (0.81mm) was advanced through the distal lumen and exited through the distal tip.No issues were identified.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.No relevant findings were identified.The ifu provided with the kit informs the user, "check lumen patency by attaching a syringe to each extension line and aspirate until free flow of venous blood is observed".The report of a catheter inter-lumen crossover was not confirmed through complaint investigation.The returned catheter met all relevant visual, dimensional, and functional requirements with no issues detected.A device history review based on sales history was performed as part of the complaint investigation, and no relevant findings were identified.The returned catheter was tested per bs en iso 10555-1 with no leaks observed.The extension lines were also evaluated for internal backflow and no backflow, leaks or evidence of a breach between the extension lines were observed.Based on the customer report and evaluation of the sample received, no problem was found with the returned device.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The complaint is reported as: cvc inserted on (b)(6) 2022 by anesthetist.On (b)(6) 2022, on aspiration of the grey lumen which was infusing noradrenaline, propofol was aspirated as well as or instead of noradrenaline in icu.Cvc removed as planned.No patient harm reported.The patient's condition is reported as fine.

• Brand Name: ARROW CVC KIT: 4-LUMEN 8.5FR X 16CM
• Type of Device: 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: 13763405
• MDR Text Key: 287249132
• Report Number: 3006425876-2022-00228
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 02/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CS-42854-HP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NORADRENALINE, PROPOFOL; NORADRENALINE, PROPOFOL