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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 Known Impact Or Consequence To Patient (2692)
Event Date 08/05/2019
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 that on (b)(6) 2019, the physician discovered during a femoral vein procedure that two of three hubs on a cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter set were occluded. After placement, the physician discovered that the red hub was the only one that was not occluded. The catheter was flushed to test its performance before the procedure and yielded satisfactory results. Additional information regarding device details has been requested but is unavailable at the time of this report. No adverse events or patient harm have been reported 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
larry pool
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key8940658
MDR Text Key156740459
Report Number1820334-2019-02150
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00827002478299
UDI-Public(01)00827002478299(17)210627(10)9166947
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 10/25/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/28/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/27/2021
Device Model NumberN/A
Device Catalogue NumberC-UTLM-701J-RSC-ABRM-HC-RD
Device Lot Number9166947
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/29/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/10/2019
Was Device Evaluated by Manufacturer? Yes
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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