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

Catalog Number EDC-00622-B

Device Problem Fluid/Blood Leak (1250)

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

Event Date 05/18/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the rn placed the catheter and got it in easily.When she flushed the catheter, blood came out of the rubber end where the needle was.No patient harm was reported.The patient's condition is reported as fine.

Event Description

It was reported the rn placed the catheter and got it in easily.When she flushed the catheter, blood came out of the rubber end where the needle was.No patient harm was reported.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4).The customer returned one catheter assembly from an endurance device.No other components from the endurance device were returned.Signs of use in the form of biological material were observed.Visual analysis did not reveal any defects or anomalies of any kind.A lab inventory 10 ml syringe was attached to the returned catheter side arm and flushed.Water was observed exiting out of the distal tip of the catheter, which is the intended function of the device.The distal end of the catheter was then occluded, and water was pressurized through the catheter assembly.No leaks were observed.Performed per ifu statement "flush catheter using a 10 ml syringe filled with normal saline for injection".Per the leak requirements listed in amrq d001357, "the catheter shall not leak liquid in accordance with the method given in annex c of bs en iso 10555-1".The distal end of the catheter body was occluded.The side arm was then attached to the leak tester and pressurized to 300kpa for 30 seconds.No leaks out of the valves or any portion of the catheter body were observed.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "ensure catheter patency prior to pressure injection to reduce risk of catheter failure and/or patient complications.Inability to obtain brisk blood return or to flush easily indicates a possible problem with the catheter and catheter should not be used".The amrq for endurance catheters was reviewed as part of this complaint investigation.The report of a leaking endurance catheter was not able to be confirmed through complaint investigation.Visual and functional analysis did not reveal any defects or anomalies of any kind.The catheter was leaked tested in accordance with iso 10555-1 and no leaks were observed.A device history record review did not reveal any relevant findings.Based on the customer report and the sample received, no problem was found with the returned device.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW EXT DWELL CATH BASIC 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: 14598555
• MDR Text Key: 293347365
• Report Number: 9680794-2022-00361
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163513
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: EDC-00622-B
• Device Lot Number: 13F20E0208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2020
• 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: N/A.; N/A.
• Patient Sex: Male