MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PREVELEAK SURGICAL SEALANT; SEALANT, POLYMERIZING

Lot Number	10831001
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Preveleak opened to field during or (operation).When attempted to be used by physician, the syringe broke.Product was not administered to the site.Fda safety report id# (b)(4).

• Brand Name: PREVELEAK SURGICAL SEALANT
• Common Device Name: SEALANT, POLYMERIZING
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; mountain view CA 94043
• MDR Report Key: 13059539
• Report Number: MW5106176
• Device Sequence Number: 3537641
• Product Code: NBE
• UDI-Device Identifier: 05413765583582
• UDI-Public: (01)05413765583582(10)10831001
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2023
• Device Lot Number: 10831001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Male