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

Lot Number	0061897576
Health Effect - Clinical Codes	Pain (1994); Alteration in Body Temperature (4568)
Date of Event	11/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Pt had subtherapeutic response to spinal administration of bupivacaine during cesarean section.Per anesthesiologist, the pt felt the "cold" prep, which is unusual.Spinals typically set up quick and the pt's sense of temperature is the first sensation to be lost.The pt also voiced that she felt more pain on the right side prior to incision during testing.The pt declined the option to have general anesthesia; was able to maintain comfort with supplemental 200 mcg of iv fentanyl in 50 mcg increments.This is the second case this day with subtherapeutic response.Ref report: mw5148621.

• Brand Name: PENCAN SPINAL NEEDLE TRAY
• Common Device Name: SPINAL ANESTHESIA KIT
• Manufacturer (Section D): B. BRAUN MEDICAL INC.
• MDR Report Key: 18245948
• Report Number: MW5148622
• Device Sequence Number: 17557622
• 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): 11/28/2023

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: 0061897576
• 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: 11/30/2023
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 29 YR
• Patient Sex: Female