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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR INTL CSF DRAINAGE BAGS N/A

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INTEGRA NEUROSCIENCES PR INTL CSF DRAINAGE BAGS N/A Back to Search Results
Catalog Number NL8508415
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Cerebrospinal Fluid Leakage (1772)
Event Date 01/29/2021
Event Type  Injury  
Manufacturer Narrative
Attempts are being made to obtain additional information. Upon completion of the investigation, a follow-up report will be submitted.
 
Event Description
A medwatch form with uf/ importer report # (b)(4) was received on 25feb2021 with the following information: a clinical risk manager reported that the external ventricular drain nl8508415 (evd) was used to assess for hourly increased intracranial pressure (icp) output. It was noted that the stop cock proximal to the patient on the left of evd was off and leaking cerebrospinal fluid (csf) onto the bed. They were unable to reattach the stopcock. Evd setup was promptly changed. Csf leak was unmeasurable as it was in the patient's bed.
 
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Brand NameINTL CSF DRAINAGE BAGS
Type of DeviceN/A
Manufacturer (Section D)
INTEGRA NEUROSCIENCES PR
road 402 north, km 1.2
road 402 north, km 1.2
anasco PR
Manufacturer (Section G)
INTEGRA NEUROSCIENCES PR
road 402 north, km 1.2
anasco PR
Manufacturer Contact
vivian nelson
1100 campus drive
princeton, NJ 
6099362319
MDR Report Key11515809
MDR Text Key253258069
Report Number2648988-2021-00005
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
PMA/PMN Number
K972994
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberNL8508415
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/25/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/07/2021
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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