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

Catalog Number NLD-15545C-21

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Awareness during Anaesthesia (1707)

Event Date 02/25/2016

Event Type  Injury  

Manufacturer Narrative

Please notice the changes made by manufacturer: date of report was updated to today's date (04/14//2016).Comment added, "the first incident was captured under the manufacturer's reference number: 2183502-2016-00791.The second incident referred to above is being captured on the manufacturer's reference number: 2183502-2016-00792." the user facility reported 2 events on 1 medwatch.The manufacturer has filed 2 separate reports to capture both events.Customer has not yet returned the device to the manufacturer for device evaluation.When and if the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.

Event Description

Two incidents.1 spinal given in or for pregnant pt.For cystoscopy.Sab placed w/o any issues.Waited 15min and pt had no effect from sa'b.Had to convert to general anesthetic.(b)(6).97614762 1 spinal given for post partum tubal.Sab took close to 12 min to "set up." surgeon still had to inject local in order keep pt comfortable.Ref # (b)(4), lot 3115757; ref# (b)(4), lot 3093098.The first incident was captured under the manufacturer's reference number: 2183502-2016-00791.The second incident referred to above is being captured on the manufacturer's reference number: 2183502-2016-00792.

Manufacturer Narrative

The actual sample was not returned for investigation.The supplier of the anaesthesia medication completed a review of manufacturing records for the reported lot and concluded that the product met with specifications at final testing.The supplier also tested retained samples from the same lot for potency.All testing found the product to meet with specifications.

• Brand Name: PORTEX® SPINAL ANESTHESIA TRAYS
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD INC.,; 10 bowman drive; keene NH 03431 0724
• Manufacturer (Section G): SMITHS MEDICAL ASD INC.,; 10 bowman drive; keene NH 03431 0724
• Manufacturer Contact: michele seliga ; 1265 grey fox rd.; st. paul, MN 55112 ; 7633833052
• MDR Report Key: 5579090
• MDR Text Key: 42796237
• Report Number: 2183502-2016-00791
• 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: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Catalogue Number: NLD-15545C-21
• Device Lot Number: 3115757
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2016
• 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 Age: 32 YR