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

Catalog Number NEPI-NLD-15597-20

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/30/2018

Event Type  Injury  

Event 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.

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 # (b)(4)) 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
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis, MN 55442
• MDR Report Key: 8323722
• MDR Text Key: 135613642
• Report Number: 3012307300-2019-00483
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 15019517115697
• UDI-Public: 15019517115697
• Combination Product (y/n): N
• PMA/PMN Number: E332605
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 04/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 03/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention