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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® SPINAL KIT; ANESTHESIA CONDUCTION KIT
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SMITHS MEDICAL ASD, INC. PORTEX® SPINAL KIT; ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number A4209-22
Medical Device Problem Code Defective Device (2588)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 10/23/2017
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that the local anesthesia contained in a portex® spinal kit was not working.No injury was reported.
 
Additional Manufacturer Narrative
No product was returned.A review of device history records and incoming records found no discrepancies or anomalies relevant to the complaint.The product fault could not be confirmed.
 
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Brand Name
PORTEX® SPINAL KIT
Common Device Name
ANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key7041188
Report Number3012307300-2017-02451
Device Sequence Number2144825
Product Code CAZ
UDI-Device Identifier20351688082548
UDI-Public20351688082548
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 12/29/2017
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 Expiration Date11/01/2018
Device Catalogue NumberA4209-22
Device Lot Number3439820
Was Device Available for Evaluation? No
Date Returned to Manufacturer11/01/2017
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/26/2017
Supplement Date Received by Manufacturer10/26/2017
Initial Report FDA Received Date11/17/2017
Supplement Report FDA Received Date12/29/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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