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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 A3288-25
Medical Device Problem Code Defective Device (2588)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
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 this complaint could not be confirmed.The complaint could not be confirmed.
 
Event or Problem Description
It was reported that the bupivacaine contained in the portex® spinal anesthesia tray was ineffective.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 Key7508204
Report Number3012307300-2018-10239
Device Sequence Number13812643
Product Code CAZ
UDI-Device Identifier00351688068753
UDI-Public00351688068753
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
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 NumberA3288-25
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 12/12/2016
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
Concomitant Medical Products
and Therapy/Usage Dates
BUPIVACAINE
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