MAUDE Adverse Event Report: SMITHS MEDICAL ASD; INC. PORTEX® SINGLE SHOT EPIDURAL TRAYS; ANESTHESIA CONDUCTION KIT

Catalog Number	NEPI-NLD-15597-20
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/20/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received indicating that the bupivicaine to a smiths medical portex® single shot epidural tray failed to work and the patient was converted to general anesthesia.There were no reported adverse patient effects.
Additional Manufacturer Narrative
An unused sample was returned for investigation.Visual evaluation of the bupivacaine ampules (lot # 87-159-ev) from the returned trays 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 lot # 87-159-ev was within specification.Review of the sterilization certificate for the tray lot number 3669767 (po # 565352) revealed that the product was processed according to validated specification requirements and parameters.Smith medical periodically monitors supplied drug components stability post ethylene oxide sterilization throughout their expiry.Our records show that the supplied drug components continue to meet potency specifications.

• Brand Name: PORTEX® SINGLE SHOT EPIDURAL TRAYS
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis, MN 55442
• MDR Report Key: 8323736
• Report Number: 3012307300-2019-00481
• Device Sequence Number: 1500734
• Product Code: CAZ
• UDI-Device Identifier: 15019517115697
• UDI-Public: 15019517115697
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: E332605
• 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): 04/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/01/2020
• Device Catalogue Number: NEPI-NLD-15597-20
• Device Lot Number: 3669767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2019
• Supplement Date Received by Manufacturer: 03/15/2019
• Initial Report FDA Received Date: 02/08/2019
• Supplement Report FDA Received Date: 04/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Congenital Anomaly; Required Intervention; Disability