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

Model Number IPN918758

Device Problem Obstruction of Flow (2423)

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

Event Date 04/28/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported "during the insertion of the catheter, there was no back flow during the flush of the medial line (no perforation observed).The flow back on proximal and distal lines were good.".The device was replaced.No clinical consequence for the patient.

Manufacturer Narrative

Qn#(b)(4).The customer returned one 3-lumen cvc for analysis.Signs of use in the form of biological material were observed inside the medial extension line.After performing functional testing (see below), a small blockage was encountered when flushing the medial extension line.A long pin gage was inserted through the medial lumen and large quantities of congealed biological material was observed exiting the extension line.Once cleared, the medial extension line flushed as intended.No other defects or anomalies were observed.The catheter body length from the juncture hub to the distal tip measured 167mm which is within the specification limits of 157mm-177mm per the catheter product drawing.The catheter body outer diameter measured 2.42mm which is within the specification limits of 2.39mm-2.49mm per the catheter extrusion product drawing.The medial extension line outer diameter measured 2.13mm which is within the specification limits of 2.13mm-2.21mm per the medial extension line extrusion product drawing.The medial extension line inner diameter measured 1.4478mm which is within the specification limits of 1.420mm-1.500mm per the medial extension line extrusion product drawing.A lab inventory syringe filled with water was attached to each of the three extension lines and flushed.When flushing the medial extension line, a blockage was encountered.A long pin gage was inserted through the medial lumen.Large quantities of biological material were observed exiting the medial lumen.Once cleared , the medial extension line flushed as intended.Performed per ifu statement, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)".A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)".The ifu also states, "ensure catheter patency prior to use.Do not use syringes smaller than 10 ml (a fluid filled 1 ml syringe can exceed 300 psi) to reduce risk of intraluminal leakage or catheter rupture".The report of a blocked extension line was confirmed through complaint investigation.Visual and functional analysis revealed that the medial extension line was blocked due to a build-up of congealed biological material.Once cleared, the medial extension line flushed as intended.The catheter met all relevant dimensional requirements, and a device history record review was performed with no relevant findings.Based on the customer report and the sample received, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported "during the insertion of the catheter, there was no back flow during the flush of the medial line (no perforation observed).The flow back on proximal and distal lines were good.".The device was replaced.No clinical consequence for the patient.

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 16 CM
• Type of Device: CATHETER PERCUTANEOUS
• 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: 14618027
• MDR Text Key: 293460716
• Report Number: 3006425876-2022-00510
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K862056
• 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: Initial,Followup
• Report Date: 05/18/2022

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 Model Number: IPN918758
• Device Catalogue Number: CV-12703
• Device Lot Number: 71F21G0937
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/18/2022
• Initial Date FDA Received: 06/07/2022
• Supplement Dates Manufacturer Received: 06/28/2022
• Supplement Dates FDA Received: 06/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2021
• 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: NOT REPORTED; NOT REPORTED