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

Catalog Number 3717-20

Device Problem Unknown (for use when the device problem is not known) (2204)

Patient Problems Awareness during Anaesthesia (1707); Therapy/non-surgical treatment, additional (2519)

Event Date 02/17/2014

Event Type  Injury  

Event Description

A report was received stating that a patient received insufficient local anesthesia when the suspect medical device was used.It was necessary to provide the patient with additional anesthesia in the form of inhaled analgesic gas and i.V.Administered medication.No adverse effects to patient reported.

Manufacturer Narrative

Customer has not yet returned the device to the mfr for device evaluation.When and if the device becomes available and is returned and evaluated the mfr will file a follow up report detailing the results of the evaluation.

• Brand Name: PORTEX SPINAL ANESTHESIA TRAYS
• Manufacturer (Section D): SMITHS MEDICAL MD, INC.; keene NH
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 10 bowman dr; keene NH 03431
• Manufacturer Contact: pete hirte ; 1265 grey fox rd.; st. paul, MN 55112 ; 6516287384
• MDR Report Key: 3698608
• MDR Text Key: 17954777
• Report Number: 2183502-2014-00128
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMEDNMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 03/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 3717-20
• 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: 03/18/2014
• Distributor Facility Aware Date: 02/17/2014
• Event Location: Hospital
• Date Manufacturer Received: 02/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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