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

Catalog Number	A1368-25
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported device issue was captured as instances of drug inefficacy.Smiths medical received 10 unused kits; however, per request, the product samples were destroyed and smiths medical's quality team was not able to perform an investigation.The anesthetic is a supplied item and the complaint was forwarded to the supplier.Per our supplier's report, batch record review revealed no discrepancies that may have contributed to a complaint of this nature.Results of analytical testing performed on manufacturing retain drug samples met specifications.A review of the kit's device history records, relevant to smiths lot, revealed no deviations or abnormalities related to the reported issue.Based on the information provided, the reported complaints were not confirmed.
Event or Problem Description
It was reported that either the bupivacaine or lidocaine contained in the portex® spinal anesthesia tray failed to deliver the appropriate numbness following spinal administration to the patient.Information concerning which of the aforementioned drugs contributed to the incident could not be determined.The patient underwent general anesthesia as a result of the incident.No patient death or serious injury was reported in connection with the 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: 7507943
• Report Number: 3012307300-2018-10137
• Device Sequence Number: 13918926
• Product Code: CAZ
• UDI-Device Identifier: 20351688037012
• UDI-Public: 20351688037012
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• 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 Expiration Date: 01/31/2018
• Device Catalogue Number: A1368-25
• Device Lot Number: 3036604
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2016
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2016
• 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