MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. DESIGN OPTIONS®; EPIDURAL ANESTHESIA KIT

Catalog Number	551148
Medical Device Problem Code	Labelling, Instructions for Use or Training Problem (1318)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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: customer received product labeled with ref.551148 but there is another label sticker on the side that references id (b)(4).No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Four (4) photos were submitted to the manufacturer for evaluation.Through visual examination of the photos, it was observed that the extra label on the blister package is not placed on the package at the b.Braun medical inc.Plant.A review of our supply chain and packaging processes was conducted; b.Braun medical inc.Does not attach the label in question on this f/g product.Based on the investigation, the reported issue is not a result of our packaging or labeling process.This product is manufactured and packaged at b.Braun medical inc.And dispatched to distributors.These distributors then forward the products to the end customers.The most probably root cause could be the distributor affixes an additional label, and repackaged partial boxes that were not part of b.Braun medical inc.'s original finished good packaging.The distributor then continued with their handling and redistribution process.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).Nine (9) unopened samples and four (4) photographs were provided for evaluation.All samples and photographs were visually inspected by the kits mrb business unit, and it was confirmed that the extra label on the blister package was not placed on the package at this manufacturing plant.It should be noted that eight of the nine kits were labeled from b.Braun as item # 551148 lot # 0062041300, manufacture date 11/24/2025, and one kit was labeled as item # 332258 lot # 0062049877, and manufacture date 12/19/2025, almost a month apart.Based on the investigation findings, the reported defect was not confirmed to be a result of our packaging or labeling process.Upon receiving the samples and photographs of the incorrect, extra label on the packaging of the blisters, a review of our supply chain and packaging processes was conducted.B braun does not attach the label in question on this finished good product.This product is manufactured and packaged at this facility and dispatched to distributors.These distributors then forward the products to the end customers.The most probable root cause can be that the distributor affixes an additional label, and repackaged partial boxes that were not part of b.Braun's original finished good packaging.The distributor then continued with their handling and re-distribution processes.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.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: DESIGN OPTIONS®
• Common Device Name: 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: 24845263
• Report Number: 2521402-2026-00397
• Device Sequence Number: 12998587
• Product Code: OGE
• UDI-Device Identifier: 04046964186219
• UDI-Public: (01)04046964186219
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/04/2026

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: 551148
• 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: 04/01/2026
• Supplement Date Received by Manufacturer: Not provided; 04/01/2026
• Initial Report FDA Received Date: 04/10/2026
• Supplement Report FDA Received Date: 04/17/2026; 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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