• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

COOK INC REDO SINGLE LUMEN TPN CATHETER SET Back to Search Results
Model Number G07933
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Sepsis (2067); No Code Available (3191)
Event Date 06/12/2020
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. Initial reporter customer (person): (b)(6). Reporter occupation: interventional radiology/vascular access team lead. 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). 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 patient developed sepsis after a redo single lumen tpn catheter was placed. The tpn catheter was removed and replaced with a like device (gpn: g07933, lot # 13007915). The patient was described as, "independent and following the st marks protocol. " events that include another instance of sepsis and two separate split lines have been reported for the same patient that reference the patient identifier: (b)(6). Additional information regarding the device and event have been requested, but are unavailable at the time of this report.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
jason crouch
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key10868375
MDR Text Key217161523
Report Number1820334-2020-02153
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberG07933
Device Catalogue NumberC-TPNS-6.5-90-REDO
Device Lot Number9673773
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 Received01/25/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/15/2019
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: 11/19/2020 Patient Sequence Number: 1
-
-