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

Catalog Number	A4014-25
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/19/2016
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 #'s 600453a and confirmed that the reported lot continues to meet all specifications.See attached pfizer evaluation report.
Event or Problem Description
It was reported that the bupivacaine contained in the portex® spinal anesthesia tray was ineffective.It was also noted that motor block was not achieved.There was full sensation on the anterior knee, but no sensation on the posterior knee.As a result of this incident, the patient was placed on general anesthesia.There were no complications associated with the placement.No patient death or serious injury was reported in connection with this incident.

• 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: 7508022
• Report Number: 3012307300-2018-10191
• Device Sequence Number: 16436509
• Product Code: CAZ
• UDI-Device Identifier: 20351688080094
• UDI-Public: 20351688080094
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• 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: No Information
• Device Catalogue Number: A4014-25
• 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: Not provided
• 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