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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
Model Number NEPI-NLD-15583C-21
Device Problem Infusion or Flow Problem (2964)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/25/2019
Event Type  malfunction  
Manufacturer Narrative
Possible lot numbers: 3702073 or 37020272.
 
Event Description
Information was received that the bupivicaine in a smiths medical portex spinal anesthesia tray did not work during a procedure. It was noted that the "patient didn't have any complication and didn't have any anatomical issue that lead to spinal insertion complication. Due to complications from the kit not working, the patient was forced to receive general anesthesia".
 
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Brand NamePORTEX SPINAL ANESTHESIA 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 Key8446738
MDR Text Key139681101
Report Number3012307300-2019-01513
Device Sequence Number1
Product Code CAZ
UDI-Device Identifier35019517115684
UDI-Public35019517115684
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 03/24/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/24/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNEPI-NLD-15583C-21
Device Catalogue NumberNEPI-NLD-15583C-21
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 Received02/22/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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