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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
No device was returned for evaluation. A review of the device history record, incoming record, and sterilization certificate found no discrepancies. Assay testing was performed on the drug lot by the supplier and found that the product was processed according to validated specifications. Based on the evidence, no fault was able to be confirmed.
 
Event Description
It was reported that a patient was not receiving pain relief with the 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 Key7149758
MDR Text Key195840791
Report Number3012307300-2017-02629
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 02/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/01/2019
Device Catalogue NumberNEPI_NLD_15583C-21
Device Lot Number3504495
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: 12/27/2017 Patient Sequence Number: 1
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