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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® SPINAL KITS; ANESTHESIA CONDUCTION KIT
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SMITHS MEDICAL ASD, INC. PORTEX® SPINAL KITS; ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number 4966-25
Medical Device Problem Code Defective Device (2588)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 09/14/2016
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Review of device history records and incoming records found no discrepancies or anomalies relevant to the complaint.The anesthetic is a supplied item and the complaint notification was forwarded to the supplier.Records analysis was performed by the supplier for bupivacaine-marcaine lot #'s 622453a and confirmed that the reported lot continues to meet all specifications.Possible causes of lack of effect may be administration technique or patient anatomical variations, including pathological or psychological factors.
 
Event or Problem Description
It was reported that a marcaine medication in portex® spinal kits was ineffective.No patient injury reported.
 
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Brand Name
PORTEX® SPINAL KITS
Common Device Name
ANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key7508148
Report Number3012307300-2018-10217
Device Sequence Number1225069
Product Code CAZ
UDI-Device Identifier00351688034529
UDI-Public00351688034529
Combination Product (Y/N)N
Initial Reporter StateTX
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 Number4966-25
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 09/27/2016
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
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