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

Catalog Number NLD-15545C-21

Device Problem Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/10/2017

Event Type  malfunction  

Manufacturer Narrative

Visual evaluation of one bupivacaine ampules from the five returned trays found no visible non-conformities.The drug liquid was found to be clear (colorless) with no particulates visible inside the vial.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 # 67-227-ev, was within specification.Review of the sterilization certificate for the tray lot number 3364833 (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 drugs components continue to meet potency specifications.Complaint history review found no other complaints relevant to this bupivacaine drug lot number, reported in this complaint.The anesthetics are supplied items and the complaint notification was forwarded to the supplier.Possible causes of lack of effect may be administration technique or patient anatomical variations, including pathological or psychological factors.

Event Description

It was reported that during use of a portex® spinal anesthesia trays there was slow/reduced medication effectiveness.

• Brand Name: PORTEX® SPINAL ANESTHESIA TRAY
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL NORTH AMERICA; 10 bowman drive; keene NH 03431
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 7508245
• MDR Text Key: 108165748
• Report Number: 3012307300-2018-10278
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 20351688078602
• UDI-Public: 20351688078602
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/26/2018
• Device Catalogue Number: NLD-15545C-21
• Device Lot Number: 3364833
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/09/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/10/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1