MAUDE Adverse Event Report: B. Braun Medical Inc. PENCAN®; SPINAL ANESTHESIA KIT

Catalog Number	333851
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/24/2026
Type of Reportable Event	Malfunction

• Brand Name: PENCAN®
• Common Device Name: SPINAL ANESTHESIA 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: elena reifenstein ; 824 12th ave; bethlehem, PA 18018 ; +1(833)425-1464
• MDR Report Key: 50173285
• Report Number: 2521402-2026-00777
• Device Sequence Number: 18650684
• Product Code: OFU
• UDI-Device Identifier: 04046964180606
• UDI-Public: (01)04046964180606(11)260309(17)280531(10)0062061267
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/07/2026

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 Catalogue Number: 333851
• Device Lot Number: 0062061267
• 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: 07/24/2026
• Initial Report FDA Received Date: 08/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/09/2026
• 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