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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD; INC. PORTEX® SINGLE SHOT EPIDURAL TRAYS ANESTHESIA CONDUCTION KIT
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SMITHS MEDICAL ASD; INC. PORTEX® SINGLE SHOT EPIDURAL TRAYS ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number NEPI-NLD-15597-20
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/20/2018
Event Type  Injury  
Event Description
Information was received indicating that the bupivicaine to a smiths medical portex® single shot epidural tray failed to work and the patient was converted to general anesthesia. There were no reported adverse patient effects.
 
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Brand NamePORTEX® SINGLE SHOT EPIDURAL TRAYS
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
SMITHS MEDICAL ASD; INC.
6000 nathan lane n
minneapolis, MN 55442
Manufacturer (Section G)
SMITHS MEDICAL NORTH AMERICA
10 bowman drive
keene NH 03431 0724
Manufacturer Contact
dave halverson
6000 nathan lane n
minneapolis,, MN 55442
7633833310
MDR Report Key8323736
MDR Text Key135613793
Report Number3012307300-2019-00481
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
E332605
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/01/2020
Device Catalogue NumberNEPI-NLD-15597-20
Device Lot Number3669767
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/25/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/15/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/30/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 02/08/2019 Patient Sequence Number: 1
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