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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR SPECIAL EVD 10-110 W/O Y SITE N/A

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INTEGRA NEUROSCIENCES PR SPECIAL EVD 10-110 W/O Y SITE N/A Back to Search Results
Catalog Number SP0090
Device Problem Break (1069)
Patient Problem Cerebrospinal Fluid Leakage (1772)
Event Date 10/24/2018
Event Type  Injury  
Manufacturer Narrative
The device was not yet 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.
 
Event Description
An integra account manager reported on behalf of the customer that the luer lock of the sp0090 special evd 10-110 w/o y site sheared off, specifically where the transducer was connected on (b)(6) 2018. The device was used on a (b)(6) year old female patient. There was no injury and surgery delay noted. Additional information was received on 06dec2018 stating that there was cerebrospinal fluid (csf) leak noted from the port which alerted the staff to the problem. The customer also mentioned that similar breakage at the transducer stopcock has occurred at least five other times in the last year; however, the customer did not provide any further details on it.
 
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Brand NameSPECIAL EVD 10-110 W/O Y SITE
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 Key8184367
MDR Text Key131008340
Report Number2648988-2018-00055
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
Report Date 12/05/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberSP0090
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 Received01/02/2019
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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