MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. DESIGN OPTIONS®; EPIDURAL ANETHESIA TRAY

Catalog Number	555076
Medical Device Problem Code	Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2023
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
Brief inquiry description: fx catheter was found in do tray 555076.Detailed inquiry description: 555076 is supposed to include soft tip catheter.No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).No samples or photos were submitted to the manufacturer for evaluation.Retained samples with the same lot number were inspected per specification; the kit did contain the correct catheter.Based on the investigation, the reported defect was not observed in the retained samples.A review of manufacturing records was performed and indicated that there were no quality issues during the manufacturing of this lot related to the reported issue.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 ANETHESIA TRAY
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd; allentown PA 18109
• Manufacturer (Section G): B. BRAUN MEDICAL INC.; 901 marcon blvd; allentown PA 18109
• Manufacturer Contact: jonathan severino ; 861 marcon blvd; allentown, PA 18109 ; 4847197287
• MDR Report Key: 18185752
• Report Number: 2523676-2023-00763
• Device Sequence Number: 15272701
• Product Code: OGE
• UDI-Device Identifier: 04046964313417
• UDI-Public: (01)04046964313417
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2024

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
• Device Expiration Date: 06/30/2024
• Device Catalogue Number: 555076
• Device Lot Number: 0061889682
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/21/2023
• Supplement Report FDA Received Date: 09/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/22/2023
• 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