MAUDE Adverse Event Report: B. BRAUN & COMPANY/ B. BRAUN MEDICAL INC. B. BRAUN PENCAN SPINAL NEEDLE TRAY; SPINAL ANESTHESIA KIT

Lot Number	0061939318
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A 7% bupivacaine from tray was not effective to control pt's pain.

• Brand Name: B. BRAUN PENCAN SPINAL NEEDLE TRAY
• Common Device Name: SPINAL ANESTHESIA KIT
• Manufacturer (Section D): B. BRAUN & COMPANY/ B. BRAUN MEDICAL INC.; bethlehem PA 18018
• MDR Report Key: 20090587
• Report Number: MW5158915
• Device Sequence Number: 20730473
• Product Code: OFU
• UDI-Device Identifier: 04046964180590
• UDI-Public: 04046964180590
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/21/2024

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 Lot Number: 0061939318
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/27/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 7% BUPIVACAINE
• Patient Age: 35 YR
• Patient Sex: Female