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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

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COOK INC FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number N/A
Device Problems Break (1069); Fracture (1260)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
Device name: cook spectrum minocycline/rifampin impregnated double lumen central venous catheter tray. Additional pro code: ljs. Occupation: unknown. 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 an unknown component of the cook spectrum minocycline/rifampin impregnated double lumen central venous catheter tray broke/fractured. Information regarding event details and patient outcome have been requested, but is unavailable at this time.
 
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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 Key8759882
MDR Text Key150029441
Report Number1820334-2019-01612
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K021557
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/23/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/03/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberC-UDLMY-801J-ABRM-HC-FST-A
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/15/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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