MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ARTERIAL CATH. SET: 20 GA X 8CM; CATHETER, PERCUTANEOUS

Catalog Number DE-00820P-KN

Device Problems Deformation Due to Compressive Stress (2889); Migration (4003)

Patient Problem Insufficient Information (4580)

Event Date 01/19/2023

Event Type  malfunction  

Event Description

It was reported that "catheter slipped out of skin and kinked off".No further event details were available at the time of this report.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).The customer returned one 20 ga arterial catheter for evaluation.Signs of use were observed on the catheter body and inside the extension lines.Visual inspection of the catheter revealed a kink near the juncture hub.Microscopic examination confirmed the kinking.No other defects or anomalies were observed.The kink was located 8mm from the juncture hub.The catheter body total length measured 82 mm, which is within the specifications of 82-86mm per product drawing.The catheter outer diameter measured 1.05mm, which is within the specifications of 1.04-1.09mm per product drawing.A lab inventory 10ml syringe filled with water was attached to the returned catheter and flushed.Water was observed exiting out of the distal tip with little to no issue.Performed per ifu statement , "maintain catheter patency according to institutional policies, procedures and practice guidelines.All personnel who care for patients with peripheral intravascular devices must be knowledgeable about effective management to prolong catheter's dwell time and prevent injury".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, "care should be exercised that the catheter is not inadvertently kinked at the hub area when securing catheter to the patient as this may result in catheter damage, breakage and loss of arterial monitoring capabilities".The ifu also states, "do not apply tape , staples, or sutures directly to the catheter body to reduce risk of damaging catheter, impeding catheter flow , or adversely affecting monitoring capabilities.Secure only at indicated stabilization locations".The report of a kinked catheter was confirmed through complaint investigation of the returned sample.Visual analysis revealed one distinct kink towards the juncture hub of the catheter.Despite this, the catheter met all relevant dimensional and functional requirements, and a device history record review based on sales history 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.

Event Description

It was reported that "catheter slipped out of skin and kinked off".No further event details were available at the time of this report.

• Brand Name: ARROW ARTERIAL CATH. SET: 20 GA X 8CM
• 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: 16386171
• MDR Text Key: 309683757
• Report Number: 3006425876-2023-00138
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: DE-00820P-KN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2023
• 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: NOT REPORTED; NOT REPORTED