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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
Catalog Number 50318
Device Problems Flaked (1246); Device Contaminated During Manufacture or Shipping (2969)
Patient Problem No Patient Involvement (2645)
Event Date 01/03/2020
Event Type  malfunction  
Manufacturer Narrative
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 residue was visible in the packaging of a cook ventriclear catheter. The device was not used because the customer stated that upon observation, it appeared that "the coating was coming off the device inside the initial packaging. " at this point, it is unknown if the residue was the coating of the device or foreign matter. Additional information regarding event details has been requested but is not currently available. No adverse effects have been reported.
 
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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
jennifer canada
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key10028218
MDR Text Key198734323
Report Number1820334-2020-00913
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 user facility
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/14/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/13/2020
Device Catalogue Number50318
Device Lot Number9323518
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 Received08/06/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/07/2018
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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