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

Catalog Number	NEPI-49661C-25
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/28/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received that the bupivacaine in smiths medical spinal single shot tray was ineffective.It was reported to not be anesthetizing the patient and as a result, have had to put the patient to sleep for procedure.No patient injury resulted.
Additional Manufacturer Narrative
One sealed portex spinal single shot tray was returned for evaluation.Visual evaluation of the bupivacaine-marcaine ampule from the returned tray found no visible non-conformities.The drug liquid was found to be clear (colorless) with no particulates visible inside the vials.Review of device history records and incoming records found no discrepancies or anomalies relevant to the complaint.Assay testing, performed by the supplier prior to release of bupivacaine was within specification.Review of the sterilization certificate for the tray revealed that the product was processed according to validated specification requirements and parameters.The customer complaint could not be confirmed.

• 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: 7720174
• Report Number: 3012307300-2018-02927
• Device Sequence Number: 1452098
• Product Code: CAZ
• UDI-Device Identifier: 15019517115505
• UDI-Public: 15019517115505
• 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,Followup
• Report Date (Section B): 10/31/2018

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: 10/01/2020
• Device Catalogue Number: NEPI-49661C-25
• Device Lot Number: 3624028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2018
• Supplement Date Received by Manufacturer: 09/25/2018
• Initial Report FDA Received Date: 07/25/2018
• Supplement Report FDA Received Date: 11/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1