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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 37160-20
Medical Device Problem Code Missing Value Reason (3192)
Health Effect - Clinical Code Patient Problem/Medical Problem (2688)
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 # 57-237-ev and confirmed that the reported lot continues to meet all specifications.See attached pfizer 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 failed.
 
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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 Key7508044
Report Number3012307300-2018-10201
Device Sequence Number16568720
Product Code CAZ
UDI-Device Identifier00351688055722
UDI-Public00351688055722
Combination Product (Y/N)N
Initial Reporter StateMI
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 Date08/31/2017
Device Catalogue Number37160-20
Device Lot Number3153751
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 08/26/2016
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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