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

Catalog Number 49663C-25

Device Problem Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

All drugs in the kit are supplied items and the complaint notification was forwarded to the supplier.Batch record review performed by the supplier for bupivacaine lot # 501113a, lidocaine lot # is 521853a and epinephrine lot # is 490603a revealed no discrepancies that may have contributed to a complaint of this nature.The results of potency testing met specification at the time of final release.Possible causes of lack of effect may be administration technique or patient anatomical variations, including pathological or psychological factors.The complaint could not be confirmed.

Event Description

It was reported that during use of a portex® spinal anesthesia tray the drugs in the kits are not working.

• 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: 7507894
• MDR Text Key: 108157780
• Report Number: 3012307300-2018-10090
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00351688057788
• UDI-Public: 00351688057788
• 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: 12/31/2016
• Device Catalogue Number: 49663C-25
• Device Lot Number: 2998544
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/02/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/20/2015
• 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