MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. PENCAN; SPINAL ANESTHESIA KIT

Model Number	333868
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Upon opening the tray packaging, it was discovered that the tape that is used to seal the blue wrap around the tray was contaminated with gray material (? dust).Was not used / no pt (patient) harm.

• Brand Name: PENCAN
• Common Device Name: SPINAL ANESTHESIA KIT
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 824 12th ave; bethlehem PA 18018
• MDR Report Key: 21872518
• Report Number: 21872518
• Device Sequence Number: 18117609
• Product Code: OFU
• UDI-Device Identifier: 04046964180859
• UDI-Public: 04046964180859
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/11/2025
• Report Date (Section F): 04/11/2025

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 Model Number: 333868
• Device Catalogue Number: 333868
• Device Lot Number: 0061970674
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/21/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/21/2025
• 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: 74 YR
• Patient Sex: Female
• Patient Weight: 95 KG
• Date Report Sent to FDA: 04/11/2025