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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® SPINAL ANESTHESIA TRAY; ANESTHESIA CONDUCTION KIT
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SMITHS MEDICAL ASD, INC. PORTEX® SPINAL ANESTHESIA TRAY; ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number 15548-20
Medical Device Problem Code Missing Value Reason (3192)
Health Effect - Clinical Code Patient Problem/Medical Problem (2688)
Date of Event 01/05/2015
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The anesthetic is a supplied item and the complaint notification was forwarded to the supplier.Batch record review performed by the supplier for bupivacaine lot # 31496ev revealed no discrepancies that may have contributed to a complaint of this nature.Retained file samples were tested for product potency.The results of potency testing met specification.See attached hospira evaluation report.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 during use of a portex® spinal anesthesia tray bupivacaine and dextrose is not effective.
 
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Brand Name
PORTEX® SPINAL ANESTHESIA TRAY
Common Device Name
ANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key7507771
Report Number3012307300-2018-10003
Device Sequence Number1224426
Product Code CAZ
UDI-Device Identifier00351688053551
UDI-Public00351688053551
Combination Product (Y/N)N
Initial Reporter StateAZ
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Health Professional
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 Health Professional
Device Expiration Date06/06/2015
Device Catalogue Number15548-20
Device Lot Number2739406
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 01/05/2015
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, DEXTROSE
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