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

Catalog Number CS-27702-E

Device Problem Fluid/Blood Leak (1250)

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

Event Date 11/10/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported a central venous catheter was inserted in the right subclavian vein by the icu physician and when performing "tube sealing operations", the extension line was found leaking.The catheter was removed and a new one inserted on the opposite site.No patient injury or complication reported.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4).The customer returned a 2-l cvc catheter for evaluation.Signs of use in the form of sutures were found on the catheter body.Visual inspection of the catheter confirmed the distal extension line contained a cut parallel with the line near the luer hub.The cut was smooth, consistent with a sharp instrument such as a scalpel or scissors contacting the extension line.The total length of the catheter body measured 215 mm, which is within specifications of 207-227 mm per catheter graphic.The distal extension line was cut 2-4 mm, from the luer hub.The outer diameter of the distal extension line measured 2.426 mm, which is within specifications of 2.39-2.49 mm per distal extension line extrusion graphic.The inner diameter of the medial extension line measured 1.6764 mm , which is within specifications of 1.65-1.75 mm per medial extension line extrusion graphic.The catheter was functionally tested per the instructions for use (ifu).The ifu provided with this kit states, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." when the distal line was flushed, water leaked out of the cut near the luer hub.The proximal line flushed as expected.A manual tug test confirmed the proximal and distal luer hubs were secure to their extension lines.A device history record review was performed, and no relevant findings were identified.The ifu provided with this kit warns the user, "do not secure, staple and/or suture 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 complaint of an extension line leak during use was confirmed by investigation of the returned sample.The distal extension line had a cut parallel with the line near the luer hub.The cut was smooth, consistent with a sharp object contacting the extension line.A device history record review was performed, and no relevant findings were identified.Based on the customer description and the sample returned, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend on complaints of this nature.

Event Description

It was reported a central venous catheter was inserted in the right subclavian vein by the icu physician and when performing "tube sealing operations", the extension line was found leaking.The catheter was removed and a new one inserted on the opposite site.No patient injury or complication reported.The patient's condition is reported as fine.

• Brand Name: ARROW CVC SET: 2-LUMEN 7 FR X 20 CM
• 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: 15939289
• MDR Text Key: 306028853
• Report Number: 9680794-2022-00765
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K900263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/16/2023
• Device Catalogue Number: CS-27702-E
• Device Lot Number: 71F21M0990
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2021
• 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.