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

Catalog Number A3822-25

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

Patient Problem Awareness during Anaesthesia (1707)

Event Date 08/24/2014

Event Type  Injury  

Event Description

A report was received that stated a pt received insufficient local anesthesia when the listed medical device was used during a cesarean section.It was necessary to place pt under general anesthesia during the procedure.No adverse effects to pt 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 evaluation results.

• Brand Name: PORTEX SPINAL ANESTHESIA TRAYS
• Type of Device: CAZ - ANETHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD INC; keene NH
• Manufacturer (Section G): SMITHS MEDICAL MD, INC.; 10 bowman dr; keene NH 03431
• Manufacturer Contact: pete hirte ; 1265 grey fox rd.; st. paul, MN 55112 ; 6516287384
• MDR Report Key: 4128871
• MDR Text Key: 4925552
• Report Number: 2183502-2014-00688
• 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: Other
• Type of Report: Initial
• Report Date: 09/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2014
• 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: A3822-25
• Device Lot Number: 2656115
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/15/2014
• Distributor Facility Aware Date: 08/24/2014
• Device Age: 5 MO
• Event Location: Hospital
• Date Manufacturer Received: 08/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2014
• 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