MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW EXT DWELL CATH DEVICE 20GAX8CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number EDC-00820

Device Problems Crack (1135); Fluid/Blood Leak (1250)

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

Event Date 01/24/2023

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

It was reported the patient had an extended dwell catheter which was not functioning well and another iv which was leaking.The user changed the dressing on the extended dwell catheter and when flushing, noted the catheter was cracked at the hub, the very end of the catheter most distal to the patient.All the flush leaked out of the crack.The catheter was removed.No patient harm was reported.The patient's condition is reported as fine.

Event Description

It was reported the patient had an extended dwell catheter which was not functioning well and another iv which was leaking.The user changed the dressing on the extended dwell catheter and when flushing, noted the catheter was cracked at the hub, the very end of the catheter most distal to the patient.All the flush leaked out of the crack.The catheter was removed.No patient harm was reported.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4).The customer returned one 20ga x 8cm endurance catheter with a syringe attached for evaluation.Visual inspection confirmed there was a kink in the catheter body adjacent to the juncture hub that contained a crack.The catheter body also contained some minor bending distal to the kink.The total length of the catheter body measured 84 mm , which is within specification of the nominal value 85 mm per catheter graphic.The outer diameter of the catheter body measured 0.04285", which is within specification of 0.038-0.048" 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 at 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 a kink and 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 20GAX8CM
• 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: 16405851
• MDR Text Key: 310237972
• Report Number: 9680794-2023-00098
• 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: 01/24/2023

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: EDC-00820
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/24/2023
• Initial Date FDA Received: 02/20/2023
• Supplement Dates Manufacturer Received: 02/27/2023
• Supplement Dates FDA 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: NOT REPORTED; NOT REPORTED