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

Catalog Number A3664-24

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Visual evaluation of one bupivacaine 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 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 # 62-312-ev, was within specification.Smith medical monitors supplied drug components stability post ethylene oxide sterilization throughout their expiry.Our records review found that the supplied drugs components continue to meet potency specifications.Complaint history review does not indicate any trends for the drug lot number, reported in this complaint.The anesthetic is a supplied item and the complaint notification was forwarded to the supplier.

Event Description

It was reported that the bupivacaine contained in the portex® spinal anesthesia tray was ineffective.No patient death or serious injury was reported in connection with this incident.

• Brand Name: PORTEX® SPINAL ANESTHESIA TRAYS
• 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 03431 0724
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7508193
• MDR Text Key: 108049553
• Report Number: 3012307300-2018-10237
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 20351688074857
• UDI-Public: 20351688074857
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/11/2018

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
• Device Operator: No Information
• Device Expiration Date: 12/06/2017
• Device Catalogue Number: A3664-24
• Device Lot Number: 3285799
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2017
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/06/2017
• Initial Date FDA Received: 05/11/2018
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BUPIVACAINE