MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® SPINAL TRAY; ANESTHESIA CONDUCTION KIT

Catalog Number	A3939-25
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	Awareness during Anaesthesia (1707)
Date of Event	04/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Smiths medical has received the sample device.A full evaluation is anticipated, but not yet begun, as the device is currently in transit to the investigation site.
Event or Problem Description
It was reported that a spinal block failed during use of a portex® spinal tray.The patient was undergoing a caesarean section at the time of the event.The patient's legs went numb, but a full block could not be accomplished.The doctor reported good visualization of cerebrospinal fluid.The doctor used general anesthesia to finish the procedure.No permanent injury was reported.See mfr: 3012307300-2017-01070.
Additional Manufacturer Narrative
Nine trays were returned for evaluation.Visual inspection of the returned trays found no visual non-conformities on the ampules.The drug was clear and without particulates.A review of the device history record found no discrepancies related to the complaint.A review of the sterilization certificate for the given lot found that the product was processed to validated specifications.Based on the evidence, the fault could not be confirmed and the root cause was unable to be determined.

• Brand Name: PORTEX® SPINAL TRAY
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 6581280
• Report Number: 3012307300-2017-01072
• Device Sequence Number: 1134272
• Product Code: CAZ
• UDI-Device Identifier: 20351688079005
• UDI-Public: 20351688079005
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K965017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/15/2018
• Device Catalogue Number: A3939-25
• Device Lot Number: 3249509
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2017
• Supplement Date Received by Manufacturer: 06/19/2017
• Initial Report FDA Received Date: 05/22/2017
• Supplement Report FDA Received Date: 07/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other