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

Catalog Number NLD-15597-20

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

Patient Problem Awareness during Anaesthesia (1707)

Event Date 03/19/2015

Event Type  Injury  

Manufacturer Narrative

Manufacturer completed the entire form.Additional manufacturer narrative: 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

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

• Brand Name: PORTEX SPINAL ANESTHESIA TRAYS
• Type of Device: CAZ - ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.,; keene NH
• Manufacturer (Section G): SMITHS MEDICAL MD, INC.; 10 bowman drive; keene NH 03431
• Manufacturer Contact: pete hirte ; 1265 grey fox rd.; st. paul, MN 55112 ; 6516287384
• MDR Report Key: 4643639
• MDR Text Key: 21852269
• Report Number: 2183502-2015-00184
• 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 Facility
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 03/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2016
• Device Catalogue Number: NLD-15597-20
• Device Lot Number: 2847801
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/24/2015
• Distributor Facility Aware Date: 03/19/2015
• Device Age: 3 MO
• Event Location: Hospital
• Date Manufacturer Received: 03/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2014
• 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