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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 G07935
Device Problem Fluid Leak (1250)
Patient Problems No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/18/2021
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. Customer (person): postal code (b)(6). Pma/510(k): 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. (b)(4) - the patient required an additional procedure to remove and replace the device. 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 leak was discovered at the "top part" of the redo double lumen tpn catheter set in a two-year old patient. The catheter was inserted on (b)(6) 2020. After the leakage was discovered, the device was explanted on (b)(6) 2021 and a new device was placed. This was the first event of leakage identified for this patient. The second occurrence is referenced in the report with patient identifier: (b)(6).
 
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Brand NameREDO DOUBLE LUMEN TPN CATHETER SET
MDR Report Key11300867
MDR Text Key231114339
Report Number1820334-2021-00286
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 08/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG07935
Device Catalogue NumberC-TPNS-5.0D-65-12-REDO
Device Lot Number9942199
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/28/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/22/2019
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: 02/09/2021 Patient Sequence Number: 1
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