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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 N/A
Device Problems Partial Blockage (1065); Use of Device Problem (1670)
Patient Problem No Code Available (3191)
Event Date 01/20/2020
Event Type  Injury  
Manufacturer Narrative
Device name: cook spectrum minocycline/rifampin impregnated triple 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 that after placement in the right femoral vein, the blue lumen of a cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter set was found to be occluded. Consequently, the physician "pump but doesn't have a blood". The occlusion was discovered right after device placement. Before the initial procedure, all lumens were filled with saline before introduction of the device into the patient. Nutrition medicine was being delivered through the device. The physician used saline to flush the unused lumen and then locked it. As part of hospital protocol, it was requested that heparinized saline not be used on a patient that had brain surgery. Ultimately, the patient required placement of a new device. No other adverse effects to the patient have been reported.
 
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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 Key9756889
MDR Text Key192750665
Report Number1820334-2020-00466
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K081113
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 05/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/26/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/19/2021
Device Model NumberN/A
Device Catalogue NumberC-UTLM-701J-RSC-ABRM-HC-RD
Device Lot Number9553215
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/02/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/17/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/27/2019
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: 02/26/2020 Patient Sequence Number: 1
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