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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL, ASD, INC. PORTEX® SPINAL ANESTHESIA TRAY; ANESTHESIA CONDUCTION KIT
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SMITHS MEDICAL, ASD, INC. PORTEX® SPINAL ANESTHESIA TRAY; ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number NEPI-NLD-15545C-21
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Awareness during Anaesthesia (1707)
Event Date 07/01/2018
Event Type  Injury  
Event Description
It was reported that at an anesthesia department meeting it was discovered that a portex® spinal anesthesia tray had not worked at all.
 
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Brand Name
PORTEX® SPINAL ANESTHESIA TRAY
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
Manufacturer Contact
dave halverson
6000 nathan lane north
minneapolis, MN 55442
7633833310
MDR Report Key7759175
MDR Text Key116309674
Report Number3012307300-2018-03181
Device Sequence Number1
Product Code CAZ
UDI-Device Identifier15019517115611
UDI-Public15019517115611
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 Physician
Type of Report Initial
Report Date 08/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date03/01/2020
Device Catalogue NumberNEPI-NLD-15545C-21
Device Lot Number3630580
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/13/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/08/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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