MAUDE Adverse Event Report: SMITHS MEDICAL, ASD, INC. PORTEX® SPINAL ANESTHESIA TRAY; ANESTHESIA CONDUCTION KIT

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  

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.

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.

• 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 03431 0724
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7135840
• MDR Text Key: 95529357
• Report Number: 3012307300-2017-02628
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 15019517115680
• UDI-Public: 15019517115680
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• 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 Received: 12/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NEPI-NLD-15583C-21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/17/2018
• 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 Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 37 YR
• Patient Weight: 61