MAUDE Adverse Event Report: BAXTER FIBRIN SEALANT TISSEEL; SYRINGE PISTON

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.

• Brand Name: FIBRIN SEALANT TISSEEL
• Type of Device: SYRINGE PISTON
• Manufacturer (Section D): BAXTER; westlake village CA 91362
• MDR Report Key: 6335760
• MDR Text Key: 67711767
• Report Number: MW5067915
• Device Sequence Number: 1
• Product Code: FMF
• Reporter Country Code: US
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Lot Number: VND4R082
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Weight: 92