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

Catalog Number 49661C-25

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

Patient Problems Awareness during Anaesthesia (1707); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Customer has not returned the device to the manufacturer for device evaluation.If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.

Event Description

It was reported that a portex® spinal anesthesia tray was used for a cesarian section.It was observed that the user had a "positive swirl" two times and the patient's anesthesia level was deemed appropriate for the procedure.It was noted that 25mcg of fentanyl was added to the included bupivacaine dose.When the user made an incision, the patient experienced intense pain and was unable to lay still for the procedure.The patient was intubated to complete the procedure.No permanent injury was reported.

Manufacturer Narrative

Six sealed trays of marcaine-bupivacaine ampules (lot number 3318794) were returned for investigation.Visual inspection of six of the ampules from the returned trays found no visible non-conformities.The drug liquid was found to be clear (colorless) with no particulates visible inside the vials.Review of the device history record and incoming records found no discrepancies or anomalies relevant to the complaint.Assay testing, which was performed by the supplier prior to release of the lot found that the reported lot was within specification.Review of the sterilization certificate for the reported lot number revealed that the product was processed according to validated specification requirements and parameters.Smiths medical monitors supplied drug components stability post ethylene oxide sterilization throughout their expiry.Records find that the supplied drug components continue to meet potency specification.Investigation was unable to confirm the reported issue and found that the devices operated as intended.

• Brand Name: PORTEX® SPINAL ANESTHESIA TRAYS
• 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: lisa perz ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833074
• MDR Report Key: 6439268
• MDR Text Key: 71033354
• Report Number: 3012307300-2017-00762
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 30351688047117
• UDI-Public: 30351688047117
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 04/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 04/03/2018
• Device Catalogue Number: 49661C-25
• Device Lot Number: 3318794
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2016
• 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