MAUDE Adverse Event Report: SMITHS MEDICALASD, INC. PORTEX SPINAL ANESTHESIA TRAYS

Catalog Number 49663C-25

Device Problem Insufficient Information (3190)

Patient Problem Awareness during Anaesthesia (1707)

Event Type  Injury  

Event Description

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

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.

• Brand Name: PORTEX SPINAL ANESTHESIA TRAYS
• Manufacturer (Section D): SMITHS MEDICALASD, INC.; keene NH
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 10 bowman drive; keene NH 03431
• Manufacturer Contact: pete hirte ; 1265 grey fox rd.; st. paul, MN 55112 ; 6516287384
• MDR Report Key: 4617683
• MDR Text Key: 5654846
• Report Number: 2183502-2015-00144
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 03/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2015
• Device Catalogue Number: 49663C-25
• Device Lot Number: 2704948
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• 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): Required Intervention