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

Catalog Number A3939-25

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Awareness during Anaesthesia (1707)

Event Date 04/20/2017

Event Type  Injury  

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 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: 3012307300-2017-01072.

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
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL NORTH AMERICA; 10 bowman drive; keene NH 03431 0724
• Manufacturer Contact: jennifer meng ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833078
• MDR Report Key: 6581270
• MDR Text Key: 75616449
• Report Number: 3012307300-2017-01070
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 20351688079005
• UDI-Public: 20351688079005
• 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: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2016
• 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): Hospitalization; Other