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

Catalog Number	3716-20
Medical Device Problem Code	Missing Value Reason (3192)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of device history records and incoming records found no discrepancies or anomalies relevant to the complaint.The anesthetic is a supplied item and the complaint notification was forwarded to the supplier.Records analysis was performed by the supplier for bupivacaine-marcaine lot # 57-237-ev and confirmed that the reported lot continues to meet all specifications.Possible causes of lack of effect may be administration technique or patient anatomical variations, including pathological or psychological factors.
Event or Problem Description
It was reported that during use of the portex® spinal anesthesia tray bupivacaine failed.

• Brand Name: PORTEX® SPINAL ANESTHESIA TRAY
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7508034
• Report Number: 3012307300-2018-10202
• Device Sequence Number: 11228163
• Product Code: CAZ
• UDI-Device Identifier: 00351688055722
• UDI-Public: 00351688055722
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2017
• Device Catalogue Number: 3716-20
• Device Lot Number: 3153751
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2016
• Initial Report FDA Received Date: 05/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1