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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR CSF DRAINAGE SYSTEM USED WITH POLE MOUNT SYSTEM N/A

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INTEGRA NEUROSCIENCES PR CSF DRAINAGE SYSTEM USED WITH POLE MOUNT SYSTEM N/A Back to Search Results
Catalog Number 10-110
Device Problems Break (1069); Crack (1135); Leak/Splash (1354)
Patient Problems Cerebrospinal Fluid Leakage (1772); No Consequences Or Impact To Patient (2199)
Event Date 12/10/2018
Event Type  Injury  
Manufacturer Narrative
The device is not available for 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 mfr. Report number: 2648988-2019-00013, 2648988-2019-00015, 2648988-2019-00016, 2648988-2019-00017.
 
Event Description
This is 2 of 5 reports. A risk management specialist that a 10110 csf drainage system was cracked. Additional information was received on 01-feb-2019 indicating that the external ventricular drain (evd) set up was reinstated. On (b)(6) 2018, a break in the evd tubing occurred at the neck of the stopcock port where the evd was attached to the transducer, rendering the evd incapable of measuring intracranial pressure (icp). The evd was then clamped in two places: proximally nearest to the patient and distally at the distal stopcock to prevent exposure. Plan for evd to be removed. Additional information has been requested.
 
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Brand NameCSF DRAINAGE SYSTEM USED WITH POLE MOUNT SYSTEM
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
kimberly shelly
311 enterprise drive
plainsboro, NJ 08536
6099362393
MDR Report Key8333201
MDR Text Key139060382
Report Number2648988-2019-00014
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
PMA/PMN Number
K920156
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/18/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number10-110
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 Received06/04/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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