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

Model Number	ADS201808
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The preveleak surgical sealant was defective as pieces were broken in the package.This was discovered and it was not used on the patient.

• Brand Name: PREVELEAK SURGICAL SEALANT
• Common Device Name: SEALANT, POLYMERIZING
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; 25212 w. illinois route 120; round lake IL 60073
• MDR Report Key: 19559225
• Report Number: 19559225
• Device Sequence Number: 4734802
• Product Code: NBE
• UDI-Device Identifier: 05413765583582
• UDI-Public: (01)05413765583582(10)HA231251(17)251213(240)ADS201808(30)1
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/13/2024
• Report Date (Section F): 06/13/2024

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
• Device Model Number: ADS201808
• Device Catalogue Number: ADS201808
• Device Lot Number: HA231251
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/17/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/18/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Sex: Male
• Patient Weight: 94 KG
• Patient Race: White
• Date Report Sent to FDA: 06/13/2024