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

Catalog Number A4103-22

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/17/2016

Event Type  malfunction  

Manufacturer Narrative

The anesthetics are a supplied items and the complaint notification was forwarded to the supplier.Investigation was performed by the supplier for bupivacaine lot # 54-438-ev and revealed no discrepancies that may have contributed to a complaint of this nature.The product met specification prior to 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 the portex® spinal anesthesia trays had mixed needles.One of the cases had mixed sprotte and quincke needles in the tray.In addition, it was alleged that bupvivaine contained in the tray was ineffective.As a result of this issue, general anesthesia was used on the patient.No patient death or serious injury was reported.

• 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 NH 03431 0724
• Manufacturer Contact: dave halverson ; 6000 nathan lane north6000 nat; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7507975
• MDR Text Key: 108157655
• Report Number: 3012307300-2018-10162
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 20351688081091
• UDI-Public: 20351688081091
• 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: Health Professional
• Device Expiration Date: 05/31/2017
• Device Catalogue Number: A4103-22
• Device Lot Number: 3119842
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/17/2017
• Initial Date FDA Received: 05/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2015
• 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