MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC KIT: 3-LUMEN 7 FR X 20 CM; CATHETER, PERCUTANEOUS

Catalog Number ASK-15703-KR

Device Problem Obstruction of Flow (2423)

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

Event Date 06/26/2023

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

It was reported the catheter was placed in the internal jugular vein and when the user attempted to aspirate blood after placement of the catheter, blood could not be aspirated from the distal lumen.The catheter was removed and replaced, and the procedure completed without problem.No patient injury or harm reported.The patient's condition is reported as fine.

Event Description

It was reported the catheter was placed in the internal jugular vein and when the user attempted to aspirate blood after placement of the catheter, blood could not be aspirated from the distal lumen.The catheter was removed and replaced, and the procedure completed without problem.No patient injury or harm reported.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4).The customer returned one, opened cvc kit for analysis.The 3-lumen cvc will be analyzed as part of this complaint investigation.Signs of use in the form of biological material was observed inside the catheter body.After failing functional testing, a blockage was encountered when flushing the medial extension lines.Visual and microscopic examination of the medial skive hole revealed a build-up of dried biological material.This dried biological material was removed, and the catheter flushed as intended.Therefore, the dried biological material is the cause of the blockage.The catheter body length from the juncture hub to the distal tip measured 217mm, which is within the specification limits of 207mm-227mm per the catheter product drawing.The catheter body outer diameter measured 2.45mm, which is within the specification limits of 2.39mm-2.49mm per the catheter extrusion product drawing.A lab inventory syringe filled with water was attached to all three extension lines and flushed.No defects were observed when flushing the distal and proximal lumens; however, a blockage was encountered when flushing the medial lumen.A long pin gage was inserted through the medial lumen and large quantities of congealed biological material was observed exiting the medial skive hole.Once cleared of biological material, 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 instructions for use (ifu) provided with this kit warns the user, "ensure catheter patency prior to use.Do not use syringes smaller than 10 ml (a fluid filled 1 ml syringe can exceed 300psi) to reduce risk of intraluminal leakage or catheter rupture." the report of a blocked catheter was confirmed through complaint investigation.Visual and functional analysis revealed a build-up of biological material inside the medial extension line.Once cleared, the medial line flushed as intended.The catheter met all relevant dimensional requirements, and a device history record review did not reveal any 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.

• Brand Name: ARROW CVC KIT: 3-LUMEN 7 FR X 20 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: 17394000
• MDR Text Key: 319792716
• Report Number: 3006425876-2023-00692
• 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: 06/28/2023

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: ASK-15703-KR
• Device Lot Number: 71F22D1678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/28/2023
• Initial Date FDA Received: 07/25/2023
• Supplement Dates Manufacturer Received: 08/15/2023
• Supplement Dates FDA Received: 08/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2022
• 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