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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION EXTERNAL CSF DRAINAGE SYSTEM COLLECTION BAG SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

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INTEGRA LIFESCIENCES CORPORATION EXTERNAL CSF DRAINAGE SYSTEM COLLECTION BAG SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Model Number NL8508415
Device Problems Connection Problem (2900); Detachment of Device or Device Component (2907)
Patient Problem Cerebrospinal Fluid Leakage (1772)
Event Date 01/29/2021
Event Type  malfunction  
Event Description
Evd (external ventricular drain) assessed for hourly icp (increased intracranial pressure) output. It was noted that the stop cock proximal to the patient on the left evd was off and leaking csf (cerebrospinal fluid) onto the bed. Unable to re-attach stopcock. Evd setup was promptly changed.
 
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Brand NameEXTERNAL CSF DRAINAGE SYSTEM COLLECTION BAG
Type of DeviceSHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
Manufacturer (Section D)
INTEGRA LIFESCIENCES CORPORATION
1100 campus rd
princeton NJ 08540
MDR Report Key11300708
MDR Text Key230946697
Report Number11300708
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 01/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNL8508415
Device Catalogue NumberNL8508415
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/29/2021
Event Location Hospital
Date Report to Manufacturer02/09/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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