MAUDE Adverse Event Report: PFM MEDICAL CPP SA TITA JET LIGH II; PORT

Model Number 61.636.83.077-K

Device Problem Material Puncture/Hole (1504)

Patient Problem Extravasation (1842)

Event Date 06/04/2020

Event Type  Injury  

Manufacturer Narrative

A complete investigation into the reported problem was performed.Investigation of the return product excludes the leakage of the port as cause of the reported problem.Incorrect puncture to access the port is the most probable cause.In addition, the use of nippers to connect the click connector is probable despite ifu recommendation as it can cause catheter damage, the issue is attributed to user error.

Event Description

The patient had installed on (b)(6) 2020 a port system in the left subclavian vein, under ultrasound navigation, without features.Direct and reverse blood flow free.The first course of chemotherapy (b)(6) 2020.At the second use (on a 48-hour infusion of chemotherapy) after 12 hours, there was swelling in the place of the installed port system, burning in the circle of the reservoir and along the course of the catheter.When examining the place of the installed catheter (b)(6) 2020 the dark color of the skin is visualed along the path of the catheter and the place of the installed reservoir.When checking the patency with a 20ml syring, we ass the reverse and direct blood flow freely.A decision was made to remove the port system.

• Brand Name: TITA JET LIGH II
• Type of Device: PORT
• Manufacturer (Section D): PFM MEDICAL CPP SA; all. du quartz 9; 2300 la chaux-de-fonds ; SZ
• Manufacturer (Section G): PFM MEDICAL CPP SA; all. du quartz 9; 2300 la chaux-de-fonds ; SZ
• Manufacturer Contact: troy taylor ; 1916 palomar oaks way; suite 150; carlsbad, CA 92008 ; 7607588749
• MDR Report Key: 16113207
• MDR Text Key: 306819511
• Report Number: 3008737795-2023-00005
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: NOT FOR USA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 61.636.83.077-K
• Device Catalogue Number: 61.636.83.077-K
• Device Lot Number: 144354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/02/2019
• 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
• Patient Outcome(s): Required Intervention