MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. SPINAL NEEDLE TRAY

Model Number 560619

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/09/2016

Event Type  malfunction  

Event Description

Anesthesia provider have had several failed spinals with all great replacements.The failure is possibly by bupivacaine when desired affects of medication were not met causing the provider to place patient under anesthesia.

• Brand Name: SPINAL NEEDLE TRAY
• Type of Device: SPINAL NEEDLE TRAY
• Manufacturer (Section D): B. BRAUN MEDICAL INC. ; bethlehem PA 18018 3524
• MDR Report Key: 5772211
• MDR Text Key: 48891822
• Report Number: 5772211
• Device Sequence Number: 1
• Product Code: BSP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/27/2016

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: 05/01/2017
• Device Model Number: 560619
• Device Lot Number: 61452626
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/14/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/27/2016
• 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