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U.S. Department of Health and Human Services

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

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BD BD SPINAL ANESTHESIA TRAY; ANESTHESIA TRAYS Back to Search Results
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.
 
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Brand Name
BD SPINAL ANESTHESIA TRAY
Type of Device
ANESTHESIA TRAYS
Manufacturer (Section D)
BD
MDR Report Key5049230
MDR Text Key24956760
Report NumberMW5055872
Device Sequence Number1
Product Code CAZ
Reporter Country CodeUS
Number of Events Reported1
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
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator No Information
Device Catalogue Number405621
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/27/2015
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
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