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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR ACCUDRAIN EVD SYSTEM -WITH ONE WAY VALVE N/A

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INTEGRA NEUROSCIENCES PR ACCUDRAIN EVD SYSTEM -WITH ONE WAY VALVE N/A Back to Search Results
Catalog Number INS-8401
Device Problem Break (1069)
Patient Problem Cerebrospinal Fluid Leakage (1772)
Event Type  Injury  
Manufacturer Narrative
An investigation has been initiated based on the reported information. Upon completion of the investigation, a follow-up report will be submitted.
 
Event Description
A facility reported that during use of the accudrain evd system (ins-80401), the medical staff observed csf leakage, apparently located at the lower part just above the yellow drain valve, above the broken part (so the connection under the 3 ways valve). The edv had to be clamped while awaiting its change which caused an increase of the patient's intracranial pressure. The patient was initially in the anesthesia - icu before his arrival in surgical icu. The medical staff did not report any shock that led to the breakage. Additional information has been requested.
 
Event Description
N/a.
 
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Brand NameACCUDRAIN EVD SYSTEM -WITH ONE WAY VALVE
Type of DeviceN/A
Manufacturer (Section D)
INTEGRA NEUROSCIENCES PR
road 402 north, km 1.2
road 402 north, km 1.2
anasco PR 00610
Manufacturer (Section G)
INTEGRA NEUROSCIENCES PR
road 402 north, km 1.2
anasco PR 00610
Manufacturer Contact
vivian nelson
1100 campus drive
princeton, NJ 08540
6099362319
MDR Report Key11327479
MDR Text Key239466035
Report Number2648988-2021-00002
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
PMA/PMN Number
K042825
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Pharmacist
Type of Report Initial,Followup,Followup
Report Date 04/19/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberINS-8401
Device Lot Number5013070
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer02/15/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/16/2021
Was Device Evaluated by Manufacturer? Yes
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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