MAUDE Adverse Event Report: COOK INC REDO SINGLE LUMEN TPN CATHETER SET FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problem Partial Blockage (1065)

Patient Problems Unspecified Infection (1930); Skin Irritation (2076); Impaired Healing (2378); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(6). This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported that a foreign body was found in the proximal end of the lumen of a redo single lumen tpn catheter after tpn placement. This catheter was originally placed on (b)(6) 2017. The catheter has been damaged in the past, so a first repair was performed on (b)(6) 2018 and a second repair was performed on (b)(6) 2019. After the second repair of the catheter, no force was exerted on the catheter. The patient had since been complaining about irritation at the incision site, so an abdominal x-ray was performed. They were able to see a "rod" at the site of the first repair, but they also noticed another obstruction on the image at the insertion site into the skin, of which they are not sure what it is. The "hard rod", which is positioned flat at the insertion site, seems to cause local irriation as well as the development of granulation tissue. The granulation has been treated with silver nitrate but they don't think they will be able to treat the local irritation as they view it as "this 'rod' continues to exert pressure at the site". It has also been noticed that the "rod" seems to move inside the catheter, as x-rays from may and december show it in different places. This obstruction has not impaired lumen functionality as they are still able to administer and sample through the catheter. Additional notes indicated that a dilator was used prior to catheter advancement. The placement site was the percutaneous translumbal puncture of the vena cava inferior from the right site of the body. The patient is allergic to tegaderm dressing and has had multiple catheters placed in the past. The fluids being infused through the line are as follows: -nacl 0. 9%, 1000ml, 1x /week. -nacl 0. 9%, 1000ml + 40meq kcl, 2x /week. -nacl 0. 9%, 1000ml + 3g mgso4, 2x /week. -nahco3 1. 4%, 500ml, 1x/week. -taurosept 2% to lock the catheter if not in use -during the last hospitalization, antibiotics (systemic and locksolution) were also administered for the local infection on the insertion site. The maintenance protocol of the catheter is as follows: -transparent dressing (mepitel film- anti allergic): 1x/week, or change dressing if loose, dirty or wet (protocol before the local infection problem started). -since local infection: daily use of nacl 0. 9% to clean, braunol to disinfect the insertion site and cover with cosmopore dressing (because of leakage). -10ml of nacl 0. 9% to flush pulsatile the catheter after deconnecting the iv bags. -after flushing, the catheter was locked with 1. 5ml taurosept. No other adverse effects have been reported for this incident.

• Brand Name: REDO SINGLE LUMEN TPN CATHETER SET
• Type of Device: FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC.; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jennifer canada ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 9494889
• MDR Text Key: 175902489
• Report Number: 1820334-2019-03149
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K950118
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: C-TPNS-6.5-90-REDO
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 12/19/2019 Patient Sequence Number: 1