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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC VENTRICLEAR DRAINAGE CATHETER SET NHC CATHETER, VENTRICULAR (CONTAINING ANTIBIOTIC 0R ANTIMICROBIAL AGENTS)

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COOK INC VENTRICLEAR DRAINAGE CATHETER SET NHC CATHETER, VENTRICULAR (CONTAINING ANTIBIOTIC 0R ANTIMICROBIAL AGENTS) Back to Search Results
Model Number G44130
Device Problem Fluid Leak (1250)
Patient Problem Cerebrospinal Fluid Leakage (1772)
Event Date 06/17/2020
Event Type  malfunction  
Manufacturer Narrative
Occupation: principal quality engineer. 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 while using a cook ventricular drainage catheter, cerebrospinal fluid leaked around the catheter where the stitches were placed. Additional information regarding the patient, device, and event has been requested but is currently unavailable.
 
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Brand NameVENTRICLEAR DRAINAGE CATHETER SET
Type of DeviceNHC CATHETER, VENTRICULAR (CONTAINING ANTIBIOTIC 0R ANTIMICROBIAL AGENTS)
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer (Section G)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
jason crouch
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key10547141
MDR Text Key207373342
Report Number1820334-2020-01703
Device Sequence Number1
Product Code NHC
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K160223
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/13/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/10/2022
Device Model NumberG44130
Device Catalogue Number50318
Device Lot NumberNS13037539
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 Received04/08/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/02/2020
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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