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

Catalog Number	560603
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun internal report number (b)(4).A follow-up report will be provided after the examination results are available.
Event or Problem Description
According to the customer: anesthesia reported a needle breaking during a procedure on (b)(6) 2024.Reportedly a new tray was opened with no incident.No patient complications were reported as a result of this event.Reported event occurred in preparation/before use.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).No sample and one video was provided for evaluation.Upon visual inspection of the video, the hub of the needle was confirmed to be disconnected from the needle.Per the statement from the supplier, based on this investigation and without the actual failed sample true root cause could not be determined and the supplier considered this an isolated issue.As a preventative measure, a review of this complaint has been conducted with all operators of the supplier.The supplier will continue to monitor the process for this condition.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.

• Brand Name: DESIGN OPTIONS®
• Common Device Name: SPINAL ANESTHESIA KIT
• Manufacturer (Section D): B BRAUN MEDICAL INC; 901 marcon blvd.; allentown PA 18109
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 19371142
• Report Number: 2523676-2024-00531
• Device Sequence Number: 15319999
• Product Code: OFU
• UDI-Device Identifier: 04046964320842
• UDI-Public: 04046964320842
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 11/15/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2026
• Device Catalogue Number: 560603
• Device Lot Number: 0061926839
• 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: 05/07/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/22/2024
• Supplement Report FDA Received Date: 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/19/2024
• 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