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	04/13/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number: (b)(4).One photo was provided for evaluation.Visual evaluation of the photo was difficult due to the quality.It appeared to show possibly two needles, one of which was broke, or one broken needle with two parts.The provided picture does not offer the details necessary to confirm the reported defect or determine any root cause at this time.B braun kits are packaged according to blueprint specifications while inspecting for any defects or deviations from drawing (e.G.Embedded particles, dirt, missing or incorrectly assembled parts, etc.).In addition, there are incoming, in process and final functional inspections performed during the manufacturing of components and finished good items.Per the manufacturers investigation this defect is not likely to have happened during the manufacturing process.It is believed to happen during application.User will be referred to instructions for use for kit and component warnings and cautions.Instructions for use provided electronically at www.Bbraunusa.Com.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.
Event or Problem Description
As reported by the user facility: the patient underwent a scheduled cesarean section (c-section) on (b)(6) 2026.The patient was taken to the operating room (or) at approximately 07:35 and positioned for spinal anesthesia.During placement of the spinal anesthetic, the spinal needle became lodged in the patient's back and could not be removed.The needle subsequently fractured, leaving a portion retained in the patient.The c-section procedure was completed.A surgical consultation was obtained for removal of the retained needle fragment.The patient was scheduled to return to the or for retrieval of the retained device.The complaint device is not available to be returned to the manufacturer for evaluation.

• 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 ; 8334251464
• MDR Report Key: 24997985
• Report Number: 2521402-2026-00444
• Device Sequence Number: 8914040
• Product Code: OFU
• UDI-Device Identifier: 04046964180606
• UDI-Public: (01)04046964180606(11)251014(17)280122(10)0062035214
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 04/27/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 333851
• Device Lot Number: 0062035214
• 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: 04/13/2026
• Initial Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/14/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female