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U.S. Department of Health and Human Services

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

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COOK INC REDO SINGLE LUMEN TPN CATHETER SET FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
(b)(6). 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 during a procedure, a redo single lumen tpn catheter was found to be faulty. The faulty line was removed and replaced on (b)(6) 2019 with a new one. Additional information regarding the device and procedure has been requested but is unavailable at this time.
 
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Brand NameREDO SINGLE 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
larry pool
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key9124988
MDR Text Key162351074
Report Number1820334-2019-02430
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
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,Followup
Report Date 12/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/26/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/06/2021
Device Model NumberN/A
Device Catalogue NumberC-TPNS-6.5-90-REDO
Device Lot Number9120209
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/18/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/25/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/06/2018
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: 09/26/2019 Patient Sequence Number: 1
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