MAUDE Adverse Event Report: B. BRAUN B. BRAUN PENCAN SPINAL TRAY

Model Number P25BK

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Awareness during Anaesthesia (1707)

Event Date 10/31/2015

Event Type  Injury  

Event Description

These correspond to the pencan kits, the kits that are in wide use across the system.The patient is (b)(6) years old.The incident occurred on (b)(6) 2015.She was seated for the spinal in the operation room for a c-section.She was then placed supine with slight left lateral tilt to improve uteroplacental blood flow.The drug (bupivicaine 1.4 ml of 0.75 with dextrose contained in your kit) failed to set up and caused a partial block with just minimal leg numbness.We waited 10-15 minute after the nurse anesthetist placed the spinal and had no numbness of her abdomen in the area where the incision would be made.We had to put the patient to sleep with a general anesthetic.Lot #61453457, 6145013.On the same day, one of my partners had a non-obstetrical case where a spinal failed and was repeated with success on the second placement.Dose amount: 2ml, frequency: x1, route: epidural.Dates of use: (b)(6) 2015.Diagnosis or reason for use: epidural for c-section and surgery cases (non ob).Event abated after use stopped or dose reduced? yes.Event reappeared after reintroduction? yes.

• Brand Name: B. BRAUN PENCAN SPINAL TRAY
• Type of Device: B. BRAUN PENCAN SPINAL TRAY
• Manufacturer (Section D): B. BRAUN
• MDR Report Key: 5260410
• MDR Text Key: 32595907
• Report Number: MW5058192
• Device Sequence Number: 2
• Product Code: CAZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 11/25/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: P25BK
• Device Catalogue Number: 333851
• Device Lot Number: 61450136
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR