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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 Partial Blockage (1065)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/04/2016
Event Type  malfunction  
Manufacturer Narrative
Device name- cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter set.This mdr is being filed after the associated complaint was reviewed under remediation (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
 
Event Description
The customer reported that after inserting the catheter, the lumen was found to be blocked at the bifurcation.There were no injuries or additional procedures reported.
 
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Brand Name
Cook Spectrum
Type of Device
FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8128294891
MDR Report Key6877517
MDR Text Key87744745
Report Number1820334-2017-03123
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00827002535992
UDI-Public(01)00827002535992(17)171101(10)5523693
Combination Product (y/n)N
Reporter Country CodeIN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 09/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberG53599
Device Catalogue NumberC-UTLM-701J-ABRM-HC-RD-P
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/12/2017
Initial Date FDA Received09/19/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/18/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age69 YR
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