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

Catalog Number	333851
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the user facility: reporter noted that you can see right away bupivacaine crystallization semi solid yellow tinge.
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.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).No sample was provided for evaluation; however, several photographs were submitted for evaluation.Visual evaluation of the photographs showed an opened, used vial of bupivacaine identifying the reported lot and with some discoloration and crystallization in the bottom of the opened vial.Based on visual findings of the photographs, the reported defect was confirmed.However, since the ampule was opened, and the incident report did not identify any discoloration or crystallization prior to opening the drug vial, the cause of the reported defect could not be determined at the time of testing.This product is recommended to be used in accordance with the instruction for use (ifu) which states, "shake down and inspect ampules.Prepare drugs for use by standing ampules upright in circular depressions.Caution: if cracked, cloudy or underfilled, do not use ampule(s).Aspirate appropriate drugs using filter straw particulate matter filter with 3 ml syringe.A review of applicable procedures and inspections by personnel, including the incoming supervisor was conducted.The ampules are supplied via a supplier as a closed glass vial.Per incoming inspection, ampules are inspected for product incorrect, damage, and foreign material fluid path/non fluid path.Training records were reviewed for the inspectors involved with the reported drug lot and inspectors were appropriately trained to the incoming specification.In process inspections are performed for kits, on a round-based sampling plan and include inspections for foreign material fluid path/non fluid path, damage, and discoloration.Lastly all finished good kits are inspected per final product specification, convenience kits, for foreign material in the fluid path.All inspections completed were found with passing results.No deviations were found in the receival of the supplier purchased part or the manufacturing process of the finished good kit assembly.A review of the device history record (dhr) was performed for the reported lot number and no abnormalities or non-conformances were noted during the in process or final product inspection.The retained units were evaluated and passed the internal testing.Additionally, a five (5) year historical search was completed on the reported drug material.No additional complaints regarding foreign material/crystallization in the vial have been reported.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: 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: 23067595
• Report Number: 2521402-2025-00906
• Device Sequence Number: 9663323
• Product Code: OFU
• UDI-Device Identifier: 04046964180606
• UDI-Public: (01)04046964180606(11)250602(17)270831(10)0062000672
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 10/24/2025

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 Catalogue Number: 333851
• Device Lot Number: 0062000672
• 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: 09/11/2025
• Supplement Date Received by Manufacturer: 09/11/2025
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/02/2025
• 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 Sex: Unknown