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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INCORPORATED VENTRICLEAR CATHETER, VENTRICULAR (CONTAINING ANTIBIOTIC OR ANTIMICROBIAL AGENTS)

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COOK INCORPORATED VENTRICLEAR CATHETER, VENTRICULAR (CONTAINING ANTIBIOTIC OR ANTIMICROBIAL AGENTS) Back to Search Results
Model Number G44130
Device Problem Fracture (1260)
Patient Problem No Code Available (3191)
Event Date 10/31/2017
Event Type  malfunction  
Event Description
An external ventricular drain (evd) was placed in a patient on [date redacted]. During removal of the evd one week later, a 0. 5cm portion of the distal tip fractured and was retained. The patient was taken to surgery four days later, and this fragment was retrieved successfully. Manufacturer response for ventricular (per site reporter). Unknown. Pictures were sent to the manufacturer.
 
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Brand NameVENTRICLEAR
Type of DeviceCATHETER, VENTRICULAR (CONTAINING ANTIBIOTIC OR ANTIMICROBIAL AGENTS)
Manufacturer (Section D)
COOK INCORPORATED
750 daniels way
bloomington IN 47404
MDR Report Key7066562
MDR Text Key93221353
Report Number7066562
Device Sequence Number1
Product Code NHC
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Patient
Type of Report Initial
Report Date 11/17/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/29/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG44130
Device Catalogue Number50318
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/17/2017
Event Location Hospital
Date Report to Manufacturer11/17/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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