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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 NEPI-NLD-15597C-20
Device Problem Failure to Deliver (2338)
Patient Problems Weakness (2145); Numbness (2415)
Event Date 04/01/2018
Event Type  malfunction  
Event Description
Information was received indicating that following use of a smiths medical portex® spinal anesthesia tray the patient had diminished sensation and motor weakness; still feeling and moving legs.Subsequently, the patient was required to go under general anesthesia for the surgical procedure.There was no reported adverse effects.
 
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Brand Name
PORTEX® SPINAL ANESTHESIA TRAYS
Type of Device
ANESTHESIA 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
Manufacturer Contact
dave halverson
6000 nathan lane n
minneapolis, MN 55442
7633833310
MDR Report Key7514096
MDR Text Key108251626
Report Number3012307300-2018-01594
Device Sequence Number1
Product Code CAZ
UDI-Device Identifier15019517115710
UDI-Public15019517115710
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 other,user facility
Reporter Occupation Other
Type of Report Initial
Report Date 05/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/15/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Expiration Date10/01/2019
Device Catalogue NumberNEPI-NLD-15597C-20
Device Lot Number3566332
Was the Report Sent to FDA? No
Date Manufacturer Received04/16/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/31/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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