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

Catalog Number NLD-15597-20

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

Patient Problem Awareness during Anaesthesia (1707)

Event Date 04/07/2015

Event Type  Injury  

Event Description

A report was received stating a pt received insufficient local anesthesia when the listed med device was used.It was necessary to provide supplemental sedation medication of midazolam, propofol and fentanyl to complete the procedure and make the pt comfortable.No adverse effects to pt reported.

Manufacturer Narrative

Additional mfr 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 follow-up report detailing the results of the eval.

Manufacturer Narrative

Device evaluation: 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 SPINAL ANESTHESIA TRAYS
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; keene NH
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 10 bowman dr; keene NH 03431
• Manufacturer Contact: michele seliga ; 1265 grey fox rd.; st. paul, MN 55112 ; 6516287604
• MDR Report Key: 4774943
• MDR Text Key: 5799881
• Report Number: 2183502-2015-00335
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2015
• Device Catalogue Number: NLD-15597-20
• Device Lot Number: 2778844
• 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: 05/08/2015
• Distributor Facility Aware Date: 04/07/2015
• Device Age: 6 MO
• Event Location: Hospital
• Date Manufacturer Received: 04/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2014
• 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
• Patient Outcome(s): Other