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

Catalog Number 15548-20

Device Problem Missing Value Reason (3192)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 12/16/2014

Event Type  malfunction  

Manufacturer Narrative

The anesthetic is a supplied item and the complaint notification was forwarded to the supplier.Batch record review performed by the supplier for bupivacaine lot # 31496ev revealed no discrepancies that may have contributed to a complaint of this nature.Retained file samples were tested for product potency.The results of potency testing met specification.See (b)(6) evaluation report.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® needleless spinal anesthesia tray the drugs bupivacaine and dextrose was ineffective resulting in incomplete blocks.

• Brand Name: PORTEX® NEEDLELESS 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: 7507767
• MDR Text Key: 108147489
• Report Number: 3012307300-2018-10001
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00351688053551
• UDI-Public: 00351688053551
• 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: 06/30/2015
• Device Catalogue Number: 15548-20
• Device Lot Number: 2739406
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/05/2015
• Was Device Evaluated by Manufacturer?: No
• 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