MAUDE Adverse Event Report: SMITHS MEDICAL PORTEX SPINAL ANESTHESIA TRAYS; ANESTHESIA CONDUCTION KIT

Catalog Number A4135-25

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

Patient Problem Awareness during Anaesthesia (1707)

Event Date 09/03/2015

Event Type  Injury  

Manufacturer Narrative

Sample was not returned to smiths medical for investigation.However, end user returned one ampule of same lot to the supplier for evaluation.The returned ampule testing found the product to meet specifications.A review of manufacturing records for the reported lot was also completed by the supplier 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.

Event Description

A report was received stating a patient received insufficient local anesthesia when the listed medical device was used.It was necessary to place patient under general anesthesia.No adverse effects to patient reported.

• Brand Name: PORTEX SPINAL ANESTHESIA TRAYS
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL; 10 bowman drive; keene NH 03431
• Manufacturer (Section G): SMITHS MEDICAL; 10 bowman drive; keene NH 03431
• Manufacturer Contact: michele seliga ; 1265 grey fox rd; st. paul, MN 55112 ; 6516287604
• MDR Report Key: 5180717
• MDR Text Key: 29367470
• Report Number: 2183502-2015-00809
• 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: Physician
• Type of Report: Initial
• Report Date: 10/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 12/31/2016
• Device Catalogue Number: A4135-25
• Device Lot Number: 2973409
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2015
• 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