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

Catalog Number	NEPI-NLD-15597-20
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a portex® spinal kit did not work on the patient.It is believed the drug contained in the kit was "weak".No injury was reported.
Additional Manufacturer Narrative
No device was returned for analysis.A review of the device history records did not identify any discrepancies or anomalies related to the complaint.Assay testing by the supplier found the drug within specification.A review of the sterilization records was performed and met validated specification requirements.Based on the evidence, a root cause was unable to be determined.No product quality problem could be confirmed.

• Brand Name: PORTEX® SPINAL KIT
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7228882
• Report Number: 3012307300-2018-00202
• Device Sequence Number: 19079560
• Product Code: CAZ
• UDI-Device Identifier: 15019517115697
• UDI-Public: 15019517115697
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,Followup
• Report Date (Section B): 03/16/2018

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: 03/01/2019
• Device Catalogue Number: NEPI-NLD-15597-20
• 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: 01/09/2018
• Supplement Date Received by Manufacturer: 03/02/2018
• Initial Report FDA Received Date: 01/30/2018
• Supplement Report FDA Received Date: 03/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1