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

Catalog Number NEPI-3717-20

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Inadequate Pain Relief (2388)

Event Date 11/10/2020

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 bupivicaine 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".

• Brand Name: SPINAL (SDD) 25G W/DRUGS
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 10945533
• MDR Text Key: 219500035
• Report Number: 10945533
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NEPI-3717-20
• Device Lot Number: 4030937
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/18/2020
• Event Location: Hospital
• Date Report to Manufacturer: 12/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 10220 DA
• Patient Weight: 69