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

Catalog Number A4240-25

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/18/2016

Event Type  malfunction  

Manufacturer Narrative

Review of device history records and incoming records found no discrepancies or anomalies relevant to the complaint.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.The anesthetic is a supplied items and the complaint notification was forwarded to the supplier.Records analysis was performed by the supplier for bupivacaine lot #'s 57-237-ev and confirmed that the reported lot continues to meet all specifications.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 a bupivacaine medication in portex® spinal kits was ineffective and general anesthesia was used.No patient injury reported.

• Brand Name: PORTEX® SPINAL KITS
• 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 0724
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 7508133
• MDR Text Key: 108157901
• Report Number: 3012307300-2018-10213
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 15019517049879
• UDI-Public: 15019517049879
• 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,user faci
• Reporter Occupation: Physician
• 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: No Information
• Device Catalogue Number: A4240-25
• Device Lot Number: 3205523
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1