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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 01/09/2019
Event Type  Injury  
Manufacturer Narrative
The device is not expected 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. Linked to mfg. Report numbers: 9612007-2019-00005 and 9612007-2019-00006.
 
Event Description
This is 3 of 3 reports. This is in regards to the third patient. A distributor reported on behalf of the customer that there was leakage of the "91011a" external drainage set (eds). The device was in contact with the patient. There was no patient injured. The event led to an increase in surgery time. Additional information received on (b)(6) 2019 indicated that the items in question were only released to the operating room and some of the wards in november and december. Majority of the stock was used for emergency cases and with the night staff. It was reported that the 'junior surgeons' assumed the leak from the burettes of the 910110a was their fault (thinking it was their surgical technique errors) and just changed the external ventricular drain (evd). They did not report the problem to their seniors. The first complaint to the distributor was (b)(6) 2019 when the neurocharge witnessed the problem and recorded the batch. They did three (3) cases ( 3 patients ) on the morning of (b)(6) 2019 and discarded seven (7) units due to leaks.
 
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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 Key8294545
MDR Text Key134654918
Report Number9612007-2019-00007
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,health pr
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/11/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/31/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number910110A
Device Lot Number2788074
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 Received01/31/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/18/2018
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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