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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-15583C-21
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Pain (1994)
Event Date 12/06/2017
Event Type  malfunction  
Manufacturer Narrative
The portex® spinal anesthesia tray was not returned. Review of the device history records, incoming records, and sterilization records found no discrepancies or anomalies. Assay testing performed by the supplier prior to release of the anesthetics were within specification for the drug lot numbers. The anesthetics are supplied items and the complaint notification was forwarded to the supplier. Based on available information and evidences, no product quality problem could be confirmed. The root cause is unconfirmed as no fault could be found.
 
Event Description
It was reported that a patient was not receiving relief with th use of a portex® spinal anesthesia tray. The patient required extra pain medications. There was no patient injury associated with this occurrence.
 
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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
7633833310
MDR Report Key7135840
MDR Text Key194408950
Report Number3012307300-2017-02628
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeUS
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 01/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNEPI-NLD-15583C-21
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/17/2018
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 Initial

Patient Treatment Data
Date Received: 12/20/2017 Patient Sequence Number: 1
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