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	05/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Ct surgeon requested to use new product (preveleak) for open heart case.Vendor was present in the case and had brought in a "sample" of the product which was in the same box that the sterile product was packaged in.Before the case, registered nurse (rn) took product from core refrigerator and placed on cart in or.During case, surgeon asked for the product.Vendor had placed the sample product in the same area as the sterile product.When the surgeon requested the preveleak, she touched one of the packages and said "do not open that one, it is my sample product".Rn opened the product which vendor had not touched.At the end of the case vendor realized that opened product was indeed the "sample" product which was labeled as non-sterile, sample.Current identified issues: 1: the vendor should not bring in sample products into the or suite.2) the sample product was in the same packaging as the actual product for use which caused confusion.3) there were no packaging differences to differentiate the sample from the sterile package.4) sticker with "sample" warning was on only one side of the box.Patient now has to be followed closely to prevent and monitor for any systemic/cardiac infection that may result of having a non-sterile product placed on his sutures.

• Brand Name: PREVELEAK SURGICAL SEALANT
• Common Device Name: SEALANT, POLYMERIZING
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; one baxter parkway; deerfield IL 60015
• MDR Report Key: 19805532
• Report Number: 19805532
• Device Sequence Number: 8389580
• Product Code: NBE
• UDI-Device Identifier: 05413765583582
• UDI-Public: (01)05413765583582
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/10/2024
• Report Date (Section F): 05/10/2024

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
• Operator of Device: Health Professional
• Device Model Number: ADS201808
• Device Catalogue Number: ADS201808
• Device Lot Number: HA240106
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/23/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/23/2024
• 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: 69 YR
• Patient Sex: Male
• Patient Weight: 103 KG
• Patient Ethnicity: Hispanic
• Date Report Sent to FDA: 05/10/2024