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

Lot Number	0061890145
Health Effect - Clinical Codes	Inadequate Pain Relief (2388); Numbness (2415)
Date of Event	08/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Describe event, problem, or product use error: pt was administered spinal bupivacaine 0.75% (1.5 ml) and spinal morphine 200 mcg at 7:30 am prior to cesarean section at l3-l4.Per anesthesia notes, she reported some numbness, but still could move legs and had extreme pain when tested.She required conversion to general anesthesia.The bupivacaine is part of a pencan spinal needle kit made by b braun.

• Brand Name: PENCAN SPINAL NEEDLE TRAY
• Common Device Name: SPINAL ANESTHESIA KIT
• Manufacturer (Section D): B. BRAUN MEDICAL INC.
• MDR Report Key: 18266545
• Report Number: MW5148738
• Device Sequence Number: 11751205
• Product Code: OFU
• UDI-Device Identifier: 04046964180590
• UDI-Public: 04046964180590
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Lot Number: 0061890145
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/04/2023
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MORPHINE.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 30 YR
• Patient Sex: Female