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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC COOK SPECTRUM FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

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COOK INC COOK SPECTRUM FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number G53599
Device Problem Complete Blockage (1094)
Patient Problems Fever (1858); Chills (2191); No Code Available (3191)
Event Date 01/27/2020
Event Type  Injury  
Manufacturer Narrative
Device name: cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter set. (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 a the lumen of a cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter was blocked, resulting in an interruption of treatment. The catheter was inserted on (b)(6) 2020 for improving nutrition. A "blocked 2nd catheter" was reported on (b)(6) 2020. The catheter was removed and a new catheter was placed in the right internal jugular vein within 72 hours. The replacement of the catheter resulted in an interruption of planned treatment. The patient was reported to have experienced fever, chills, and "rigor" due to this occurrence. Additional information regarding product and event details has been requested but is currently unavailable.
 
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Brand NameCOOK SPECTRUM
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 Key9693193
MDR Text Key190557552
Report Number1820334-2020-00324
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K033843
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/11/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG53599
Device Catalogue NumberC-UTLM-701J-ABRM-HC-RD-P
Device Lot NumberNS9597533
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 Received04/13/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/18/2019
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: 02/11/2020 Patient Sequence Number: 1
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