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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 Problem Obstruction of Flow (2423)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/19/2019
Event Type  malfunction  
Manufacturer Narrative
Device name: cook spectrum minocycline / rifampin impregnated triple lumen central venous catheter set. A follow up report will be submitted should additional relevant information become available.
 
Event Description
It was reported when using a cook spectrum minocycline / rifampin impregnated triple lumen central venous catheter set during a subclavian procedure that the red hub of the device was occluded. The doctor had flushed the catheter to test patency before placement in the (b)(6) year old male patient and no issues arose. After the device was placed, the red hub was found to be occluded and the blood couldn't reflux. Nothing was injected prior to the occlusion and the patient was not on any anti-coagulants. The doctor replaced the malfunctioned device with a new one. No other adverse effects have been reported for this incident.
 
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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 Key9239611
MDR Text Key164889263
Report Number1820334-2019-02690
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00827002478299
UDI-Public(01)00827002478299(17)210716(10)9216911
Combination Product (y/n)N
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 12/19/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/25/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/16/2021
Device Model NumberN/A
Device Catalogue NumberC-UTLM-701J-RSC-ABRM-HC-RD
Device Lot Number9216911
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/23/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/03/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/08/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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