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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 INS1100
Device Problems Break (1069); Crack (1135)
Patient Problem Cerebrospinal Fluid Leakage (1772)
Event Type  Injury  
Manufacturer Narrative
The device will not 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 mfg report numbers: 2648988-2018-00044, 2648988-2018-00045 and 2648988-2018-00046.
 
Event Description
This is 1 of 4 reports.The account manager reported on behalf of the customer that the failures of breakage or leakage of fluid due to a crack occurred while using the ins1100 (csf drainage system used with pole mount system).All the breaks happened in the exact same location, at the stopcock where the fluid-coupled transducer was attached.Different patients were involved.No additional patient or product details were recorded or saved.The drains were discarded.
 
Event Description
N/a.
 
Manufacturer Narrative
The device was not returned for evaluation.The device history record can not be performed as there was no lot number provided.The reported condition could not be confirmed, and no further analysis is possible.The root cause is undetermined.(b)(4).
 
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Brand Name
CSF DRAINAGE SYSTEM USED WITH POLE MOUNT SYSTEM
Type of Device
N/A
Manufacturer (Section D)
INTEGRA NEUROSCIENCES PR
road 402 north, km 1.2
road 402 north, km 1.2
anasco PR 00610
MDR Report Key8051771
MDR Text Key126564686
Report Number2648988-2018-00043
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
PMA/PMN Number
K022554
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 10/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberINS1100
Was Device Available for Evaluation? No
Date Manufacturer Received11/15/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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