MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION SPRAY SETS; SEALANT,POLYMERIZING

Catalog Number	0600021
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abscess (1690); Pericardial Effusion (3271)
Date of Event	03/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient underwent a mitral valve repair and pulmonary artery banding for an atrioventricular septal defect wherein coseal surgical sealant, easyspray, and coseal spray set were utilized.Five days post operative (post-op) a pericardial effusion was reported (no further information conveyed).Twenty-two days post-op the patient experienced a fever (not further specified).Day twenty-three postop, a hear computed tomography scan (ct scan) was performed and it revealed suspected upper mediastinal abscess.This same day unspecified antibiotics were initiated.Forty-seven days post-op the patient had recovered from the postoperative mediastinitis.The antibiotic therapy was continued as ¿prophylactic administration¿.Pericardial effusion outcome was not reported.No further information was available at the time of this report.
Additional Manufacturer Narrative
A2: age at time of event: reported date of birth was an unspecified date in (b)(6) 2024.A4: weight: 3.554kg.Height of patient 53.5cm.E1: initial reporter address: (b)(6).G1: device manufacturer postal code: 7860.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: SPRAY SETS
• Common Device Name: SEALANT,POLYMERIZING
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - LESSINES; boulevard rene branquart 80; lessines ; BE
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 19060174
• Report Number: 1416980-2024-01564
• Device Sequence Number: 6030262
• Product Code: NBE
• UDI-Device Identifier: 00085412087788
• UDI-Public: (01)00085412087788
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: PMA P030039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 0600021
• Device Lot Number: 32023492
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2024
• Supplement Date Received by Manufacturer: 04/25/2024
• Initial Report FDA Received Date: 04/08/2024
• Supplement Report FDA Received Date: 04/30/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: COSEAL SURGICAL SEALANT; EASYSPRAY
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 2 MO
• Patient Sex: Female
• Patient Weight: 4 KG