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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-UDLM-401J-ABRM-HC
Device Problem Obstruction of Flow (2423)
Patient Problem No Code Available (3191)
Event Date 08/30/2018
Event Type  Injury  
Manufacturer Narrative
Brand name: cook spectrum minocycline/rifampin impregnated double lumen central venous catheter set. (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 a cook spectrum minocycline/rifampin impregnated double lumen central venous catheter was found to be occluded. The device was removed and discarded and a like device from the same lot was placed in the right femoral vein. This device was found to be occluded after insertion and was removed. A third device from the same lot was placed in the left femoral vein with no incident to complete the procedure successfully. As reported, the patient did not experience any adverse effects due to this occurrence and is in stable condition.
 
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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
larry pool
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key7894518
MDR Text Key120893454
Report Number1820334-2018-02697
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K033843
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/28/2020
Device Catalogue NumberC-UDLM-401J-ABRM-HC
Device Lot Number8245933
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/10/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/20/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/27/2017
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: 09/20/2018 Patient Sequence Number: 1
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