MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW MULTILUMEN CVC KIT: 3L 7 FR X 60 CM; CATHETER, PERCUTANEOUS

Catalog Number SA-18763-J

Device Problem Obstruction of Flow (2423)

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

Event Date 10/12/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that after insertion of the catheter, the user was unable to aspirate from the proximal lumen with a syringe.Therefore, the catheter was removed and replaced with a new kit.No patient harm was reported.The patient's condition is reported as fine.

Event Description

It was reported that after insertion of the catheter, the user was unable to aspirate from the proximal lumen with a syringe.Therefore, the catheter was removed and replaced with a new kit.No patient harm was reported.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4).The customer returned one 3-l cvc and the product lidstock for analysis.Signs of use in the form of dried biological material were observed on the catheter.Visual inspection of the catheter revealed no obvious defects or anomalies.The catheter body length measured 620mm, which is within the specifications of 604-624mm per product drawing.The proximal extension line outer diameter measured 2.156mm, which is within the specifications of 2.13-2.21mm per product drawing.The proximal extension line inner diameter measured 1.4478mm which is within the specifications of 1.42-1.50mm per product drawing.Functional inspection of the catheter was performed per the instructions for use (ifu) provided with the kit 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 10ml syringe to test for leaks or blockages.All extension lines flushed normally.No leaks or blockages were observed.The distal tip of the catheter was placed into a beaker with water, and water was aspirated out of the proximal extension line with a 10ml lab inventory syringe.No blockages were observed.A manual tug test confirmed all extension lines were secured to their respective luer hubs.A device history record review was performed with no relevant findings.The ifu provided with this kit warns the user, "caution: minimize catheter manipulation throughout procedure to maintain proper catheter tip position." the customer report of a blocked catheter could not be confirmed through complaint investigation of the returned sample.Functional inspection revealed all extension lines flushed normally.The catheter met all relevant dimensional requirements, and 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 MULTILUMEN CVC KIT: 3L 7 FR X 60 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: 15786198
• MDR Text Key: 306806852
• Report Number: 3006425876-2022-00946
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 10/19/2022

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 Expiration Date: 08/31/2023
• Device Catalogue Number: SA-18763-J
• Device Lot Number: 71F21C2229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/19/2022
• Initial Date FDA Received: 11/13/2022
• Supplement Dates Manufacturer Received: 12/08/2022
• Supplement Dates FDA Received: 12/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2021
• 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.