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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 A4014-25
Device Problem Defective Device (2588)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/15/2015
Event Type  malfunction  
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 641003a 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 Description
It was reported that the bupivacaine contained in the portex® spinal anesthesia tray was ineffective. There was no sensory, motor or sympathetic block. The patient was placed under general anesthesia as a result of this incident. No patient death or serious injury was reported in connection with this incident.
 
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Brand NamePORTEX® SPINAL ANESTHESIA TRAYS
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer (Section G)
SMITHS MEDICAL NORTH AMERICA
10 bowman drive
keene NH 03431 0724
Manufacturer Contact
dave halverson
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key7508286
MDR Text Key108163973
Report Number3012307300-2018-10195
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial
Report Date 05/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/11/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberA4014-25
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/11/2018 Patient Sequence Number: 1
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