MAUDE Adverse Event Report: BD BD SPINAL ANESTHESIA TRAY

Catalog Number 405637

Device Problem Insufficient Information (3190)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 02/18/2015

Event Type  Injury  

Event Description

Bupivacaine effect wore off much faster than normal in two consecutive pts.Medication typically acts for >2 hours, but today, the medication's effects wore off <1 hour.

• Brand Name: BD SPINAL ANESTHESIA TRAY
• Type of Device: BD SPINAL ANESTHESIA TRAY
• Manufacturer (Section D): BD
• MDR Report Key: 4604807
• MDR Text Key: 5470282
• Report Number: MW5041436
• Device Sequence Number: 1
• 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: 02/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 01/31/2016
• Device Catalogue Number: 405637
• Device Lot Number: B02H2370
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other