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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER FIBRIN SEALANT TISSEEL SYRINGE PISTON

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BAXTER FIBRIN SEALANT TISSEEL SYRINGE PISTON Back to Search Results
Lot Number VND4R082
Device Problem Failure to Deliver (2338)
Patient Problem Tissue Damage (2104)
Event Date 02/13/2017
Event Type  malfunction  
Event Description
The applicator would not dispense the tisseel when pushing in the plunger. The tisseel was being utilized for a dura tear during a l3-4 l4-5 laminectomy.
 
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Brand NameFIBRIN SEALANT TISSEEL
Type of DeviceSYRINGE PISTON
Manufacturer (Section D)
BAXTER
westlake village CA 91362
MDR Report Key6335760
MDR Text Key67711767
Report NumberMW5067915
Device Sequence Number1
Product Code FMF
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/14/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/14/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2018
Device Lot NumberVND4R082
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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