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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX COMBINED SPINAL EPIDURAL CUSTOM TRAY ANESTHESIA CONDUCTION KIT

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SMITHS MEDICAL ASD, INC. PORTEX COMBINED SPINAL EPIDURAL CUSTOM TRAY ANESTHESIA CONDUCTION KIT Back to Search Results
Model Number A3169-17/27
Device Problem Infusion or Flow Problem (2964)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/18/2019
Event Type  malfunction  
Event Description
Information was received that the epidural from a smiths medical portex combined spinal epidural custom tray "was uneventful, which resulted in an intrathecal catheter". The reporter also stated the issue was "recognized and the patient was taken into the operating room emergently and was able to deliver vaginally". No adverse patient effects were reported.
 
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Brand NamePORTEX COMBINED SPINAL EPIDURAL CUSTOM TRAY
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 Key8438244
MDR Text Key139380104
Report Number3012307300-2019-00484
Device Sequence Number1
Product Code CAZ
UDI-Device Identifier35019517142697
UDI-Public35019517142697
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial
Report Date 03/20/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberA3169-17/27
Device Catalogue NumberA3169-17/27
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
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? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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