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U.S. Department of Health and Human Services

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

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COOK INC REDO SINGLE LUMEN TPN CATHETER SET Back to Search Results
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.
 
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Brand NameREDO 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 Key10283685
MDR Text Key202545423
Report Number1820334-2020-01307
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeFR
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 11/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue NumberC-TPNS-4.0-65-REDO
Device Lot NumberUNKNOWN
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 Received11/02/2020
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
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