MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 7 FR X 30 CM; CATHETER PERCUTANEOUS

Catalog Number CS-14703

Device Problem Obstruction of Flow (2423)

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

Event Date 06/21/2022

Event Type  malfunction  

Event Description

It was reported "blue hub lumen blocked".The catheter was replaced.No patient harm reported.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4).

Event Description

It was reported "blue hub lumen blocked".The catheter was replaced.No patient harm reported.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4).The customer returned one 3-l cvc for evaluation.Signs of use were observed on the catheter and inside the extension lines.Visual inspection of the catheter revealed no obvious defects or anomalies.The catheter body length measured 320mm, which is within the specifications of 307-327mm per catheter product drawing.The medial extension line outer diameter measured 2.145mm, which is within the specifications of 2.13-2.21mm per the medial extension line extrusion product drawing.The medial extension line inner diameter measured 1.4732mm, which is within the specifications of 1.42-1.50mm per the medial extension line product drawing.This indicates that the wall thickness measured within specifications.Functional inspection of the catheter was performed according to the product ifu) , which states "flush each lumen with sterile normal saline for injection to establish patency and prime lumen (s)." all extension lines were flushed using a lab inventory 10cc syringe.All lumens flushed as expected.No leaks or blockages were observed in any of the extension lines.A manual tug test confirmed all extension lines were secure to their respective luer hubs.A device history record review was performed with no relevant findings.The instructions for use (ifu) provided with this kit warns the user, "do not secure, staple and/or suture directly to outside diameter of catheter body or extension lines to reduce risk of cutting or damaging the catheter or impeding catheter flow.Secure only at indicated stabilization locations." the customer report of a blocked extension line could not be confirmed through complaint investigation of the returned sample.The returned catheter met all relevant functional and dimensional requirements, and no leaks or blockages were observed in any of the extension lines.A device history record review was performed with no relevant findings.Based on these circumstances, no problem was found with the returned sample.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 30 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: 15008993
• MDR Text Key: 301016529
• Report Number: 3006425876-2022-00611
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K862056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/22/2022

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 Catalogue Number: CS-14703
• Device Lot Number: 71F21B2914
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/22/2022
• Initial Date FDA Received: 07/13/2022
• Supplement Dates Manufacturer Received: 08/09/2022
• Supplement Dates FDA Received: 08/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2021
• 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.