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

Catalog Number	333192
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
As reported by the user facility: a nurse was helping a patient out of bed and found that the catheter had broken, with some of the catheter still in the patient's back.The nurse removed the remainder of the catheter, ensuring the tip was intact.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) used catheter and connector, along with lidstock packaging were provided for evaluation.Visual evaluation of the sample showed the catheter to be torn in two pieces, approximately 14" above the tip of the catheter.The remainder of the catheter attached to the connector was pull tested per specification with passing results of 3.82 lbs.Although the catheter was observed to be broken, the defect was not confirmed to be related to the manufacturing process.Per the manufacturers investigation this defect is not likely to have happened during the manufacturing process.The reported defect is most likely attributed to handling during the clinical application.The product is recommended to be used in accordance with the instructions for use (ifu) for kit and component warnings and cautions.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.A review of the device history record (dhr) was performed for the reported lot number and no abnormalities or non-conformance's 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.

• Brand Name: ESPOCAN®
• Common Device Name: SPINAL EPIDURAL 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: 23704376
• Report Number: 2521402-2025-01541
• Device Sequence Number: 10641296
• Product Code: OFT
• UDI-Device Identifier: 04046964179266
• UDI-Public: (01)04046964179266(11)250210(17)260331(10)0061983201
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 12/12/2025

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 Expiration Date: 03/31/2026
• Device Catalogue Number: 333192
• Device Lot Number: 0061983201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2025
• Supplement Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2025
• 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