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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR LIMITORR VOLUME LIMITING EVD 20 ML N/A

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INTEGRA NEUROSCIENCES PR LIMITORR VOLUME LIMITING EVD 20 ML N/A Back to Search Results
Catalog Number INS9020
Device Problem Disconnection (1171)
Patient Problem Cerebrospinal Fluid Leakage (1772)
Event Date 11/28/2018
Event Type  Injury  
Manufacturer Narrative
The device was not returned to the manufacturer for analysis. The device history record (dhr) review did not reveal anything that could cause the reported condition. No event was generated for the provided lot and has complied with all requirements as specified in the manufacturing shop order and procedures. Failure analysis was not possible. The complaint is unconfirmed. The root cause is undetermined. (b)(4).
 
Event Description
A sales representative reported on behalf of the customer that the tubing of the ins9020 limitorr volume limiting evd 20 ml was disconnected at the stopcock. The device was currently in use by a patient but no injury and surgery delay was noted. It was reported that the physician taped back the disconnected tubing together. Additional information was received by integra on (b)(6) 2018 stating that the patient was in her 70's. The event occurred on (b)(6) 2018. Leakage was not noted until the tubing was disconnected. Amount, consistency, and color of the leakage was not specified.
 
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Brand NameLIMITORR VOLUME LIMITING EVD 20 ML
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 Key8267245
MDR Text Key133741729
Report Number2648988-2018-00096
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
PMA/PMN Number
K072929
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 11/30/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/22/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/31/2019
Device Catalogue NumberINS9020
Device Lot Number1172842
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/26/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/24/2017
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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