MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. PENCAN 25G SPINAL NEEDLE; SPINAL ANESTHESIA KIT

Lot Number	0061907116
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Pt required an urgent c-section due to arrest of cervical dilatation.Spinal for anesthesia performed.Pt with some patchy sensation.Additional anesthetic needed.Anesthesiologist states that it had good placement.

• Brand Name: PENCAN 25G SPINAL NEEDLE
• Common Device Name: SPINAL ANESTHESIA KIT
• Manufacturer (Section D): B. BRAUN MEDICAL INC.
• MDR Report Key: 18527619
• Report Number: MW5150415
• Device Sequence Number: 8221325
• Product Code: OFU
• UDI-Device Identifier: 04046964180590
• UDI-Public: 04046964180590
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/11/2024

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: 02/28/2026
• Device Lot Number: 0061907116
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/16/2024
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White