MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW EXT DWELL CATH BASIC 20GAX6CM; CATHETER INTRAVASCULAR THERAPE

Model Number IPN037864

Device Problem Obstruction of Flow (2423)

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

Event Date 12/30/2021

Event Type  malfunction  

Event Description

Endurance catheter placed in patient on (b)(6) 2021.It worked well and medications were given for 24 hours.On (b)(6) 2021, they could not flush the line.The line was removed from the patient.No patient harm.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Qn#(b)(4).The customer returned one endurance catheter and a syringe for evaluation.Visual inspection of the returned sample revealed the catheter body was bent to one side.No other clear anomalies were observed.After the catheter failed dimensional inspection (see below) , further observation revealed the area directly adjacent to the juncture hub looks stretched and elongated.The marking on the catheter looks distorted.This elongation is likely to have occurred during use and is consistent with the kinking observed.The total catheter length measured 75 mm, which is longer than the reference length dimension of 65 mm per catheter product drawing.See visual inspection for further analysis of the sample.The catheter outer diameter measured 0.043", which is within the specification of 0.041-0.045" per catheter extrusion drawing.The product ifu informs the user to "ensure catheter patency prior to pressure injection to reduce risk of catheter failure and/or patient complications." the catheter was functionally tested by using the returned syringe to flush the catheter.Water was able to exit out of the distal end of the catheter with minimal resistance.No leaks or blockages or partial blockages were observed.A manual tug test confirmed the luer hub was secured to its extension line.A device history record review was performed and no relevant manufacturing issues were identified.The instructions for use (ifu) provided with this kit warns 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.Indwelling catheter should be routinely inspected for desired patency, security of dressing, and possible migration." the customer report of a catheter blockage could not be confirmed by investigation of the returned sample.The catheter appeared sharply bent to one side and the section directly adjacent to the juncture hub appeared stretched and elongated; however, the catheter was still able to pass all relevant functional testing and no blockages were observed during functional testing of the returned catheter.A device history record review was performed with no relevant findings.Based on the investigation performed and the information provided, no problem was observed related to catheter blockage on the returned sample.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

Endurance catheter placed in patient on (b)(6) 2021.It worked well and medications were given for 24 hours.On (b)(6) 2021, they could not flush the line.The line was removed from the patient.No patient harm.The patient's condition is reported as fine.

• Brand Name: ARROW EXT DWELL CATH BASIC 20GAX6CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• 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: 13315198
• MDR Text Key: 284819919
• Report Number: 9680794-2022-00009
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 10801902133004
• UDI-Public: 10801902133004
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 08/31/2023
• Device Model Number: IPN037864
• Device Catalogue Number: EDC-00620-B
• Device Lot Number: 13F21J0282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2021
• 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