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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
Model Number A3911-25
Device Problem Infusion or Flow Problem (2964)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
Information was received that the bupivicaine in a smiths medical spinal kit did not produce an effect in the patient. It was reported the kits themselves appear to be working. Additionally, the patient did not have any anatomical issues leading to insertion complications. As a result of the incident, general anesthesia was administered to finish procedure. Event was reported to be abated after use.
 
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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
10 bowman drive
keene NH 03431 0724
Manufacturer Contact
dave halverson
6000 nathan lane north
minneapolis, MN 55442
7633833310
MDR Report Key8441437
MDR Text Key139486852
Report Number3012307300-2019-01446
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 other,user facility
Reporter Occupation
Type of Report Initial
Report Date 03/21/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/21/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/01/2020
Device Model NumberA3911-25
Device Lot Number3702072
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/19/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/06/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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