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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SPINAL (SDD) 25G W/DRUGS ANESTHESIA CONDUCTION KIT

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SMITHS MEDICAL ASD, INC. SPINAL (SDD) 25G W/DRUGS ANESTHESIA CONDUCTION KIT Back to Search Results
Model Number NEPI-3717C-20
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Inadequate Pain Relief (2388)
Event Date 09/10/2020
Event Type  malfunction  
Event Description
Two patients on the same day using the same spinal kits did not obtain adequate anesthesia. Previous failed spinal was approximately 2 months ago. Both spinal procedures were uneventful, however both had insufficient anesthesia at 30 min post-block (weak but able to move feet, incomplete sensory block). Each case required a repeat spinal which carries an increased risk of high spinal + delays cases. We were using "new" spinal kits from a different manufacturer. These kits include 0. 75% bupivacaine with dextrose used for spinal anesthetic. Both failed spinals used the bupivacaine from the kit. Bupivacaine from the anesthesia cart during the second spinals for each patient and the both worked great. Per md, "possibly a bad batch of bupivacaine in these new spinal kits. Failed spinals are infrequent and seems like too much of a coincidence to have it happen back-to-back like that with a new spinal kit".
 
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Brand NameSPINAL (SDD) 25G W/DRUGS
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key10945544
MDR Text Key219499947
Report Number10945544
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial
Report Date 11/18/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNEPI-3717C-20
Device Lot Number4030937
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/18/2020
Event Location Hospital
Date Report to Manufacturer12/04/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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