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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); Injury (2348)
Event Date 12/16/2018
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 mfr. Report number: 2648988-2019-00013, 2648988-2019-00014, 2648988-2019-00016, 2648988-2019-00017.
 
Event Description
This is 3 of 5 reports. A risk management specialist reported that a 10110 csf drainage system was cracked on (b)(6) 2018. Additional information received on 06feb2019 indicating that the connecting part of the transducer and the external ventricular drain (evd) port snapped off. There was no patient injury reported. However, the external part of the drain needed to be changed by the neuro surgeon. 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 Key8333202
MDR Text Key135951780
Report Number2648988-2019-00015
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? No
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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