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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC REDO DOUBLE LUMEN TPN CATHETER SET FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

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COOK INC REDO DOUBLE LUMEN TPN CATHETER SET FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number N/A
Device Problems Fluid Leak (1250); Material Twisted/Bent (2981)
Patient Problem No Code Available (3191)
Event Date 12/30/2019
Event Type  Injury  
Manufacturer Narrative
(b)(6). (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 during a procedure, a redo double lumen tpn catheter was bent and started leaking. The catheter was removed on the same day as the incident occurred and a new catheter was placed. Additional information has been requested regarding patient and event details but is currently unavailable.
 
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Brand NameREDO DOUBLE LUMEN TPN CATHETER SET
Type of DeviceFOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer (Section G)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
jennifer canada
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key9580714
MDR Text Key174692911
Report Number1820334-2020-00097
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K950118
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
Report Date 03/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/01/2020
Device Model NumberN/A
Device Catalogue NumberC-TPNS-5.0D-65-12-REDO
Device Lot Number8312659
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/26/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2017
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: 01/13/2020 Patient Sequence Number: 1
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