MAUDE Adverse Event Report: SMITHS MEDICAL ASD INC., PORTEX CUSTOM SINGLE SHOT SPINAL; ANESTHESIA CONDUCTION KIT

Catalog Number A4135-25

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

Patient Problem Awareness during Anaesthesia (1707)

Event Date 02/25/2016

Event Type  Injury  

Manufacturer Narrative

The customer has not yet returned the device to the manufacturer for evaluation.When and if the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results.

Event Description

User facility reported that the anesthesia drug, from the listed custom spinal kit, failed to complete a full block.The reporter explained that it was necessary to place the patient under general anesthesia.No permanent injury was reported.

Manufacturer Narrative

The actual sample was not returned for investigation.The supplier of the anaesthesia medication completed a review of manufacturing records for the reported lot and concluded that the product met with specifications at final testing.The supplier also tested retained samples from the same lot for potency.All testing found the product to meet with specifications.

• Brand Name: PORTEX CUSTOM SINGLE SHOT SPINAL
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD INC.,; 10 bowman drive; keene NH 03431 0724
• Manufacturer (Section G): SMITHS MEDICAL; 10 bowman dr.; keene NH 03431 0724
• Manufacturer Contact: michele seliga ; 1265 grey fox road; st. paul, MN 55112 ; 7633833052
• MDR Report Key: 5518880
• MDR Text Key: 40924321
• Report Number: 2183502-2016-00595
• 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: health professional,user faci
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 03/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Catalogue Number: A4135-25
• Device Lot Number: 3098880
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other