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

Catalog Number 3717C-20

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

Patient Problem Awareness during Anaesthesia (1707)

Event Type  Injury  

Event Description

(b)(4).

Manufacturer Narrative

Field samples were not returned for evaluation.The supplier of the anesthesia medication performed a complete review of their manufacturing records for the lots that were reported to potentially be associated with the product issue.The supplier concluded that the product met with specification at final testing.They also tested retained samples for potency of the same lots.All testing found the product to meet specifications with no degradation or loss of efficacy.

• 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 ASD, INC.; 10 bowman dr.; keene NH 03431
• Manufacturer Contact: pete hirte ; 1265 grey fox rd.; st. paul, MN 55112 ; 6516287384
• MDR Report Key: 4039806
• MDR Text Key: 20324625
• Report Number: 2183502-2014-00540
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• PMA/PMN Number: PREAMENDNMEN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2015
• Device Catalogue Number: 3717C-20
• Device Lot Number: 2674864
• Was Device Available for Evaluation?: No
• Device Age: 2 MO
• Date Manufacturer Received: 05/08/2014
• 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