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

Catalog Number NLD-15597-20

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Awareness during Anaesthesia (1707)

Event Type  Injury  

Event Description

A report was received stating that a pt was planned to have a ovarian mass removal when the listed device was used to administer a local anesthesia.The pt reportedly received insufficient local anesthesia; therefore, the pt was given general anesthesia.No adverse effects to pt reported.

Manufacturer Narrative

Customer has not yet returned the device to the mfr for device eval.When and if the device becomes available and is returned and evaluated, the mfr will file a f/u report detailing the results of the eval.

Manufacturer Narrative

The supplier of the anaesthesia medication preformed a complete review of their manufacturing records on product lots relevant to the report.The supplier concluded that the product met specifications at final testing.Retained samples from the reported lot were tested by the supplier for potency.All testing found the product to meet specifications with no degradation or loss of efficacy.

• Brand Name: PORTEX SPINAL ANESTHESIA TRAYS
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; keene NH
• Manufacturer (Section G): SMITHS MEDICAL, INC.,; 10 bowman drive; keene NH 03431
• Manufacturer Contact: michele seliga ; 1265 grey fox rd; st. paul, MN 55112 ; 6516287604
• MDR Report Key: 4925788
• MDR Text Key: 20126858
• Report Number: 2183502-2015-00507
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K965017
• 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: 07/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2016
• Device Catalogue Number: NLD-15597-20
• Device Lot Number: 2931436
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other