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U.S. Department of Health and Human Services

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

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COOK INC REDO SINGLE LUMEN TPN CATHETER SET FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
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.
 
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Brand NameREDO SINGLE LUMEN TPN CATHETER SET
Type of DeviceFOZ 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 Key9494889
MDR Text Key175902489
Report Number1820334-2019-03149
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K950118
Number of Events Reported1
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 Received12/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberC-TPNS-6.5-90-REDO
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/29/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/02/2020
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
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