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

Catalog Number	49661C-25
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Awareness during Anaesthesia (1707)
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported that a portex® spinal anesthesia tray was used for intrathecal anesthesia for a cesarian section when the patient had inadequate anesthesia.It was observed that the spinal needle had cerebral spinal fluid (csf) flow and 0.75% bupivacaine was injected.It was noted that there was csf aspiration at the end of the injection.The patient was observed to have "1-2 levels of anesthesia" in the abdomen and was able to move her lower extremities.The patient was converted to general anesthesia due to the event.No permanent injury was reported.
Additional 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
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 6439263
• Report Number: 3012307300-2017-00761
• Device Sequence Number: 13587738
• Product Code: CAZ
• UDI-Device Identifier: 30351688047117
• UDI-Public: 30351688047117
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K965017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2017

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?: No
• Operator of Device: 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
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/06/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/28/2017
• Supplement Report FDA Received Date: 04/22/2017
• 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