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

Catalog Number EDC-00622

Device Problem Fluid/Blood Leak (1250)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 12/27/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The complaint is reported as: the nurse checked on a report that a catheter they placed was not functioning.Upon trouble shooting the catheter, it was not flushing, the insertion site was red and irritated.As he withdrew and attempted to flush the saline leaked out of the body of the catheter close to the junction hub.Catheter was removed and patient had other functioning iv.No patient harm was reported.The patient's condition is reported as fine.

Event Description

The complaint is reported as: the nurse checked on a report that a catheter they placed was not functioning.Upon trouble shooting the catheter, it was not flushing, the insertion site was red and irritated.As he withdrew and attempted to flush the saline leaked out of the body of the catheter close to the junction hub.Catheter was removed and patient had other functioning iv.No patient harm was reported.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4).The customer returned one 6cm x 22ga endurance catheter and syringe for evaluation.Visual inspection of the sample confirmed there was one kink that contained a crack adjacent to the juncture hub.The catheter body also contained a bend.The kink in the catheter body measured approximately 1 mm from the juncture hub.The total length of the catheter body measured 64 mm, (b)(4).The outer diameter of the catheter body measured 0.03525", (b)(4).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 kink.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 one kink with a crack adjacent to the juncture hub.Due to an increased trend in endurance catheter leaks/separations, 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: 16291956
• MDR Text Key: 308778721
• Report Number: 9680794-2023-00034
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151513
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/06/2023

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 Operator: Health Professional
• Device Catalogue Number: EDC-00622
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/06/2023
• Initial Date FDA Received: 02/03/2023
• Supplement Dates Manufacturer Received: 02/24/2023
• Supplement Dates FDA Received: 02/24/2023
• 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