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	10/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the user facility: during therapy needle broke in patient.A 25 guage 1 and 1/2 hypodermic needle that was used to inject local prior moving forward with the procedure, the needle broke off leaving 3mm of needle fragment left behind the soft tissue of patient's back.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).No sample was provided for evaluation.Based on the data from the investigation we are unable to determine the root cause of the reported incident.The reported defect was unable to be confirmed.The actual defective device is a valuable tool in investigating the cause of this incident.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.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).No sample was provided for evaluation.Based on the data from the investigation, the root cause of the reported incident was unable to be determined.The reported defect was unable to be 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.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
Prior to spinal placement pt arched her back when subcutaneous local was being placed.When local needle was removed it appears that the tip was broken off and remains in the subq tissue.Surgeon aware and will perform xray to identify needle tip location.Xray was performed showing small piece remaining in subq tissue.Approximately 3mm of the needle in the soft tissue of the patients back.Manufacturer was notified on 10/17/2025.Braun tray: 333851 kit, exp date: 7/31/2027, lot ##: 0667.

• 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: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 23476245
• Report Number: 2521402-2025-01330
• Device Sequence Number: 10227715
• Product Code: OFU
• UDI-Device Identifier: 04046964180606
• UDI-Public: (01)04046964180606(11)250527(17)270731(10)0062000663
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2026

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: 0062000663
• 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: 10/17/2025
• Supplement Date Received by Manufacturer: 10/17/2025
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/27/2025
• 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
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Race: White