MAUDE Adverse Event Report: B. BRAUN AESCULAP JAPAN CO., LTD. B. BRAUN PENCAN SPINAL NEEDLE TRAY; NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Lot Number 0061645019

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

Patient Problem Tingling (2171)

Event Date 02/01/2019

Event Type  malfunction  

Event Description

Using pencan spinal tray, patient received a spinal with good return of csf using 0.75% heavy bupivacaine.Patient did not receive the expected result of the spinal.She had some heaviness/ tingling in her legs but she did not achieve surgical level of analgesia.Patient required additional medication through an epidural catheter.C-section was still able to continue under regional due to the epidural.Pencan spinal needle tray, lot# 0061645019, ref# (b)(4).Is the product compounded? no, is the product over-the-counter? no.

• Brand Name: B. BRAUN PENCAN SPINAL NEEDLE TRAY
• Type of Device: NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
• Manufacturer (Section D): B. BRAUN AESCULAP JAPAN CO., LTD.
• MDR Report Key: 8315516
• MDR Text Key: 136125480
• Report Number: MW5083810
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/05/2019

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 Expiration Date: 05/31/2020
• Device Lot Number: 0061645019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/06/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other