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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® SPINAL ANESTHESIA TRAYS; ANESTHESIA CONDUCTION KIT
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SMITHS MEDICAL ASD, INC. PORTEX® SPINAL ANESTHESIA TRAYS; ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number A4014-25
Medical Device Problem Code Defective Device (2588)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 07/26/2016
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Customer has not provided the lot number and/or returned product for evaluation.If a specific lot number information is available and/or product is returned at later date, the investigation will be re-opened.Based on the information provided the root cause could not be conducted and this complaint could not be confirmed.
 
Event or Problem Description
It was reported that the bupivacaine contained in the portex® spinal anesthesia tray was ineffective.The sensory block was there throughout the case, but the motor block only lasted for one hour.No patient death or serious injury was reported in connection with this incident.
 
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Brand Name
PORTEX® SPINAL ANESTHESIA TRAYS
Common Device Name
ANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key7507759
Report Number3012307300-2018-10194
Device Sequence Number2073817
Product Code CAZ
UDI-Device Identifier20351688080094
UDI-Public20351688080094
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 05/11/2018
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? Yes
Operator of Device No Information
Device Catalogue NumberA4014-25
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date05/11/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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