MAUDE Adverse Event Report: BD BD SPINAL ANESTHESIA TRAY; ANESTHESIA TRAYS

Catalog Number 405621

Device Problems Unexpected Therapeutic Results (1631); Device Operates Differently Than Expected (2913)

Patient Problem Therapeutic Response, Decreased (2271)

Event Type  Other  

Event Description

Multiple certified registered nurse anesthetists at our hospital reported concerns about the time to onset and effectiveness this product.They have been noticing a trend over the past 3-4 months of delayed onset (up to an hour when the onset is expected within 10 minutes) and decreased effectiveness (inadequate numbing and analgesia).In multiple cases, the effectiveness has been so diminished that they have had to use general anesthesia when the spinal anesthesia did not do as expected.They report that this is occurring on multiple pts (both orthopedic and cesarean section pts) of varying ages, sex, weight, type of surgery, etc.In addition to this, they have noticed an increased length of effectiveness, so much so that it has required an add'l 2-3 hours post-operative recovery time in order for the spinal anesthesia to wear off.They are unable to correlate any similarities among the pts in which these errors are occurring.Unfortunately, they have not been tracking lot numbers, but do state that they know there have been at least 2 different lots with problems.They will begin tracking lot numbers from this time forward.Dates of use: 3-4 months.Diagnosis or reason for use: spinal anesthesia.

• Brand Name: BD SPINAL ANESTHESIA TRAY
• Type of Device: ANESTHESIA TRAYS
• Manufacturer (Section D): BD
• MDR Report Key: 5049230
• MDR Text Key: 24956760
• Report Number: MW5055872
• 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
• Report Date: 08/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 405621
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other