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

Catalog Number 15597-20

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 12/04/2013

Event Type  Injury  

Event Description

A report was received that stated that a pt received insufficient local anesthesia when the suspect medical device was used.It was necessary to place the pt under general anesthesia during the procedure.

Manufacturer Narrative

Customer has not yet returned the device to the mfr for device eval.When and if the device becomes available and is returned and evaluated the mfr will file a f/u report detailing the results of the eval.

• Brand Name: PORTEX SPINAL ANESTHESIA TRAYS
• Type of Device: CAZ - ANESTHESIA KIT SPINAL
• Manufacturer (Section D): SMITHS MEDICAL MD, INC.; keene NH
• Manufacturer (Section G): SMITHS MEDICAL INC.; 10 bowman dr; keene NH 03431
• Manufacturer Contact: pete hirte ; 1265 grey fox rd.; st. paul, MN 55112 ; 6516287384
• MDR Report Key: 3571228
• MDR Text Key: 4048803
• Report Number: 2183502-2013-00864
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2014
• Device Catalogue Number: 15597-20
• Device Lot Number: 2555746
• 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: 01/02/2014
• Distributor Facility Aware Date: 12/04/2013
• Device Age: 1 YR
• Event Location: Hospital
• Date Manufacturer Received: 12/04/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2013
• 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