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

Catalog Number NEPI-49661C-25

Device Problem Output Problem (3005)

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

Event Date 06/28/2018

Event Type  malfunction  

Event 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.

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
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7720198
• MDR Text Key: 115064461
• Report Number: 3012307300-2018-02926
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 15019517115505
• UDI-Public: 15019517115505
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 10/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 09/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1