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

Catalog Number A3391-25

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/12/2016

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 # 52140ev revealed no discrepancies that may have contributed to a complaint of this nature.All testing was performed and was within specification requirements.Final release potency testing was confirmed at 100.4% of label claim meeting the specification 93.0%-107.0%.Retained samples for the lot in question were visually inspected by (b)(4) qualified personnel and found to be within specification.Additionally smiths medical provided (b)(4) with 10 samples lot # 52140ev from the returned product and (b)(4) visual evaluation found no problem with the ampules.A 15 ampules lot # 52140ev from the returned by the customer product were forwarded by smiths medical to the accredited laboratory for potency testing.The results of the testing met specification 93.0%-107.0%.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 the bupivacaine contained in the portex® spinal anesthesia tray was ineffective.The patient required general anesthesia as a result of this incident.No patient death or serious injury was reported in connection with this incident.

• 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 03431 0724
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7507938
• MDR Text Key: 108158374
• Report Number: 3012307300-2018-10129
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00351688069286
• UDI-Public: 00351688069286
• 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

• 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 Expiration Date: 03/31/2017
• Device Catalogue Number: A3391-25
• Device Lot Number: 3065998
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2016
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/13/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/28/2015
• 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