MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW EXT DWELL CATH DEVICE 22GAX6CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number EDC-00622

Device Problems Crack (1135); Deformation Due to Compressive Stress (2889)

Patient Problem Pain (1994)

Event Date 01/19/2023

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

It was reported the catheter was inserted on (b)(6) 2023 for ceftriaxone and flagyl administration.On (b)(6) 2023, the patient attended opat (outpatient parenteral antimicrobial therapy) and reported pain at the iv site "assessed as interstitial".The catheter was removed by rn and noted to be kinked and cracked approximately 2cm from base of catheter.No patient harm was reported.No report of a required medical intervention.The patient's condition is reported as fine.

Event Description

It was reported the catheter was inserted on (b)(6) 2023 for ceftriaxone and flagyl administration.On (b)(6) 2023, the patient attended opat (outpatient parenteral antimicrobial therapy) and reported pain at the iv site "assessed as interstitial".The catheter was removed by rn and noted to be kinked and cracked approximately 2cm from base of catheter.No patient harm was reported.No report of a required medical intervention.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4).The customer provided one video for analysis.Visual inspection of the video confirmed the catheter was leaking from the distal kink.The customer returned one 22ga x 6cm endurance catheter for evaluation.Visual inspection of the sample confirmed there were two kinks in the catheter body.One was adjacent to the catheter body and the second one was approximately 9 mm from the juncture hub and contained a crack.The kinks in the catheter body measured approximately 1 mm and 9 mm from the juncture hub.The total length of the catheter body measured 64 mm, which is within specification of the nominal value 65 mm per catheter graphic.The outer diameter of the catheter body measured 0.03560", which is within specification of 0.031-0.041" per catheter product drawing.The catheter was functionally tested per the instructions for use (ifu).The ifu provided with this kit states, "flush catheter using a 10 ml syringe filled with normal saline for injection." when the catheter was flushed with a lab inventory water filled syringe, water leaked from the crack in the second kink.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 this kit warns the user, "some disinfectants used at catheter insertion site contain solvents which can weaken the catheter material.Alcohol, acetone, and polyethylene glycol can weaken the structure of polyurethane materials.These agents may also weaken the adhesive bond between catheter stabilization device and skin.Allow insertion site to dry completely prior to applying dressing.Do not raise the catheter beyond 90 relative to the skin to avoid catheter kinking and damage." the complaint of an endurance catheter leak was confirmed by a complaint investigation of the returned sample.The catheter body contained two kinks and one crack adjacent to the juncture hub.A device history record review was performed based on a potential lot number, and no relevant findings were identified.A non-conformance has been initiated to further investigate this issue.The root cause has not yet been determined.Teleflex will continue to monitor and trend on complaints of this nature.

• Brand Name: ARROW EXT DWELL CATH DEVICE 22GAX6CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16398459
• MDR Text Key: 310154409
• Report Number: 9680794-2023-00095
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K151513
• 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: 01/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EDC-00622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/02/2023
• 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: CEFTRIAXONE AND FLAGYL; CEFTRIAXONE AND FLAGYL