MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 7 FR X 20 CM; CATHETER PERCUTANEOUS

Catalog Number CV-17702-E

Device Problem Material Puncture/Hole (1504)

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

Event Date 02/17/2023

Event Type  malfunction  

Event Description

It was reported "anesthesiologist informs that catheter is punctured".It is unknown when the alleged defect was discovered at time of report.Patient condition is reported as "fine".

Manufacturer Narrative

Qn#(b)(4).

Event Description

It was reported "anesthesiologist informs that catheter is punctured".Patient condition is reported as "fine".

Manufacturer Narrative

Qn#(b)(4).Additional information received 23-may-2320 indicates "the doctor reports that during use he observed that the catheter was punctured and exchanged it for another catheter.There was no harm to the patient." the customer returned one 2-l catheter and tray for analysis.Definite signs of use were observed within the catheter body.Visual analysis of the catheter revealed no obvious defects or anomalies.The overall length of the catheter measured 218mm which is within the specification limits of 207mm - 227mm per the catheter product drawing.The outer diameter of the catheter measured 0.09545 which is within the sp ecification limits of 0.094" - 0.098" per the catheter extrusion graphic.The catheter was functionally tested per the instructions for use (ifu) provided with this kit, which instructs "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." both extension lines were flushed, and no leaks were present.The returned catheter was then tested per bs en iso 10555-1 section 4.7.1 (amrq-000071) which states that there shall be no liquid leakage in the form of one or more falling drops when pressurized to 300 kpa for 30 seconds.The catheter was connected to lab leak tester and pressurized to 300 kpa for 30 seconds.No leaks were observed from any region of the catheter.A manual tug test confirmed that both extension lines were secure within their respective luer hubs.A device history record review was performed, and there were two findings identified.It was determined that both findings are not relevant to the event.The ifu provided with this kit informs the user " do not secure, staple and/or s uture directly to outside diameter of catheter body or extension lines to reduce risk of cutting or damaging the catheter or impeding catheter flow.Secure only at indicated stabilization locations." the customer report of a hole in the catheter body could not be confirmed through investigation of the returned sample.The catheter passed all relevant dimensional and functional requirements, and a device history record review revealed no relevant findings.Based on the customer report and the sample received, no problem was found on the returned sample.Teleflex will continue to monitor and trend on reports of this nature.

• Brand Name: ARROW CVC SET: 2-LUMEN 7 FR X 20 CM
• Type of Device: CATHETER PERCUTANEOUS
• 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: 16918718
• MDR Text Key: 315081278
• Report Number: 9680794-2023-00367
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K862056
• 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: 04/27/2023

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: CV-17702-E
• Device Lot Number: 14F20G0063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/27/2023
• Initial Date FDA Received: 05/12/2023
• Supplement Dates Manufacturer Received: 06/14/2023
• Supplement Dates FDA Received: 06/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2020
• 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: NOT REPORTED; NOT REPORTED