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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: REDO DOUBLE LUMEN TPN CATHETER SET

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REDO DOUBLE LUMEN TPN CATHETER SET Back to Search Results
Model Number N/A
Device Problem Crack (1135)
Patient Problems Scar Tissue (2060); Distress (2329)
Event Date 03/19/2020
Event Type  Injury  
Manufacturer Narrative
Common device name: not available as this device is not sold in the us, but it is considered to be clinically similar to a device that is, thus prompting this report. Occupation: unknown. 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 a male patient required a redo double lumen tpn catheter set for an unknown procedure. Some time after the procedure, the device was noted to have cracked. An additional surgery was required for the "construction" of a new device on the left side of the patient. The patient reportedly "suffered from required inpatient care and psychosocial stress". Additional information regarding the event and patient outcome has been requested but is currently unavailable.
 
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Brand NameREDO DOUBLE LUMEN TPN CATHETER SET
MDR Report Key11983790
MDR Text Key255910977
Report Number1820334-2021-01502
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 09/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberC-TPNS-5.0D-65-12-REDO
Device Lot Number9545988
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/25/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/26/2019
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: 06/11/2021 Patient Sequence Number: 1
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