MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. ANESTHESIA SUPPORT TRAY; ANESTHESIA CONDUCTION KIT

Catalog Number	332116
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).The investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.
Event or Problem Description
As reported by the user facility: our techs have noticed some moisture inside the 10 ml syringes in our kits from b braun.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One unopened sample kit, two photos and a video were provided for evaluation.Upon evaluation of the photos and video, it was observed a substance on the syringe's plunger.Following a visual evaluation of the syringes in the returned sample kit, it showed what appeared to be silicone on the plunger.For further identification, the substance found in the returned sample was tested by the r&d department and b.Braun's science and materials laboratory and confirmed that the reported "moisture" was silicone from the piston material.Since the manufacturer's investigation did not confirm the reported defect, the reported defect was not confirmed.A review of the discrepancy management system (dsms) database was performed for the reported lot number and no abnormalities or non-conformances were noted during the in process or final product inspection.A batch record review was performed, and all test results and process parameters were within specification.All syringes in the retain sample kit were visually inspected per specification for excessive silicone and no abnormalities were observed.Therefore, the defect reported by the customer could not be confirmed on the retain sample.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.

• Brand Name: ANESTHESIA SUPPORT TRAY
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 824 12th ave; bethlehem PA 18018
• Manufacturer (Section G): B. BRAUN MEDICAL INC.; 824 12th ave; bethlehem PA 18018
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 22141131
• Report Number: 2521402-2025-00036
• Device Sequence Number: 7276427
• Product Code: CAZ
• UDI-Device Identifier: 04046964177545
• UDI-Public: (01)04046964177545(11)241028(17)260630(10)0061965760
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2025

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: 06/30/2026
• Device Catalogue Number: 332116
• Device Lot Number: 0061965760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2025
• Supplement Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2024
• 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
• Patient Sex: Unknown