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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
Catalog Number C-UTLM-701J-ABRM-HC-RD-P
Device Problem Partial Blockage (1065)
Patient Problem No Code Available (3191)
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 the lumens of a cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter set were getting blocked after placement. Consequently, "sampling and medication" were unable to be done through the catheter. The catheter was flushed "with heparin frequently and managed". It was also reported that an additional catheter was inserted to continue treatment. Additional information regarding the event and device has been requested but is unavailable at this time.
 
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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 Key9718736
MDR Text Key192479751
Report Number1820334-2020-00379
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 04/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/19/2021
Device Catalogue NumberC-UTLM-701J-ABRM-HC-RD-P
Device Lot Number9459563
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 Received03/27/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/21/2019
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: 02/17/2020 Patient Sequence Number: 1
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