MAUDE Adverse Event Report: COOK INC REDO SINGLE LUMEN TPN CATHETER SET

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); No Code Available (3191)

Event Date 11/21/2019

Event Type  Injury  

Manufacturer Narrative

Common device name, g5- pma/510(k) #: these fields are not applicable to the complaint device as it is not sold in the u. S. ; however, this device is considered clinically similar to cook upic and cvc devices, thus prompting this report. Customer (person): email: (b)(6). Reporter occupation: unknown. (b)(4). 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 an infection developed after placement of a redo single lumen tpn catheter set. On (b)(6) 2019, the hospitalized child patient was transferred to a different facility's gastroenterology department due to a sasm (sensitive aureus staphylococcus) infection on the device. The device was previously implanted to be used for parenteral nutrition. As a result, the device was removed. A replacement device was implanted on (b)(6) 2019 and the patient was transferred back to the previous facility. Other events associated with this patient can be found reported under patient identifier (b)(6). Additional information regarding the patient, device, and event has been requested but is currently unavailable.

• Brand Name: REDO SINGLE LUMEN TPN CATHETER SET
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 10283685
• MDR Text Key: 202545423
• Report Number: 1820334-2020-01307
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: C-TPNS-4.0-65-REDO
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/02/2020
• 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?

• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 07/16/2020 Patient Sequence Number: 1