MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG PENCAN SPINAL NEEDLE TRAY; NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Lot Number 0061690264

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Tissue Damage (2104); Discomfort (2330)

Event Date 11/02/2019

Event Type  malfunction  

Event Description

C-section with a failed spinal.When tested, pt felt a little bit of discomfort but provider assumed it hadn't totally set up yet.Pt tolerated delivery without any problems.Then there was an extra tear on uterus that needed repair and took a little longer.At this point, pt was in extreme pain.Anesthesia provider had to supplement with fentanyl, ketamine, dilaudid, and propofol to get through the case.Previous incidents of failed spinals have been reported by anesthesia.Fda safety report id# (b)(4).

• Brand Name: PENCAN SPINAL NEEDLE TRAY
• Type of Device: NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG
• MDR Report Key: 9316924
• MDR Text Key: 166738001
• Report Number: MW5091031
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/08/2019

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
• Device Operator: Health Professional
• Device Lot Number: 0061690264
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/12/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 36 YR