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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC

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COOK INC Back to Search Results
Model Number N/A
Device Problem Material Puncture/Hole (1504)
Patient Problem Insufficient Information (4580)
Event Date 10/20/2021
Event Type  malfunction  
Event Description
It was reported that a hole was observed in the middle blue lumen hub of a cook triple lumen femoral line placed in a picu patient. This hole was visible when the line was flushed. Additional information regarding event and patient details has been requested, but is currently unavailable.
Manufacturer Narrative
This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
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Manufacturer (Section D)
750 daniels way
bloomington IN 47404
Manufacturer (Section G)
750 daniels way
bloomington IN 47404
Manufacturer Contact
jason crouch
750 daniels way
bloomington, IN 47404
MDR Report Key13636397
MDR Text Key289109743
Report Number1820334-2022-00321
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,User Facility
Reporter Occupation
Type of Report Initial
Report Date 03/01/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/01/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberN/A
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Date Manufacturer Received02/14/2022
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 Unkown