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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA NEUROSCICENCS IMPLANTS SA EXTERNAL DRAINAGE SET (EDS) EXTERNAL DRAINAGE SYSTEMS

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INTEGRA NEUROSCICENCS IMPLANTS SA EXTERNAL DRAINAGE SET (EDS) EXTERNAL DRAINAGE SYSTEMS Back to Search Results
Catalog Number 910110A
Device Problem Leak/Splash (1354)
Patient Problem Cerebrospinal Fluid Leakage (1772)
Event Date 01/11/2019
Event Type  Injury  
Manufacturer Narrative
It is unknown if the device is going to be returned to the manufacturer for analysis. The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.
 
Event Description
A distributor reported on behalf of the customer that there was leakage reported on the 910110a external drainage set. Additional information was received on 14jan2019 indicating that there were 2 units of the 910110a that did not function correctly on the male patient before the customer decided to use a different batch. Operating room time increased to one hour and 20 minutes due to the product problem where an external ventricular drain change should only take up to 45 minutes. The date of the incident was on (b)(6) 2019. It was reported that the standard procedure is for all taps to be closed during connection to the ventricular catheter and then burette and drainage bag is secured to an intravenous (iv) stand; while the patient is on operating room bed and same procedure is followed during transportation to the intensive care unit (icu). Stop cocks are opened once system is connected and secured to the iv stand. There was no patient injury reported. However, a leak was noted immediately when cerebrospinal fluid (csf) entered the burette. The location of the leak was detected on the top of the burette; before entering the burette.
 
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Brand NameEXTERNAL DRAINAGE SET (EDS)
Type of DeviceEXTERNAL DRAINAGE SYSTEMS
Manufacturer (Section D)
INTEGRA NEUROSCICENCS IMPLANTS SA
2905 route des dolines
2905 route des dolines
sophia antipolis F-069 21
FR F-06921
Manufacturer (Section G)
INTEGRA NEUROSCICENCS IMPLANTS SA
2905 route des dolines
sophia antipolis F-069 21
FR F-06921
Manufacturer Contact
kimberly shelly
311 enterprise drive
plainsboro, NJ 08536
6099362393
MDR Report Key8291035
MDR Text Key134565748
Report Number9612007-2019-00004
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
PMA/PMN Number
K032817
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/11/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number910110A
Device Lot Number2850000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/10/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/04/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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