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

Catalog Number A2832-25

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The anesthetics are a supplied items and the complaint notification was forwarded to the supplier.Batch record review performed by the supplier for bupivacaine lot #582453a revealed no discrepancies that may have contributed to a complaint of this nature.Final release potency testing for all drug components was performed and was within specification requirements.Retained file samples testing performed by the supplier met specification.See attached hospira's evaluation report.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 bupivacaine contained in the portex® spinal anesthesia tray was ineffective.The customer opened and used a new kit successfully.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: beth board ; 4420 lake boone trail; raleigh, NC 27607 ; 9197843091
• MDR Report Key: 7507952
• MDR Text Key: 108050297
• Report Number: 3012307300-2018-10147
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00351688061761
• UDI-Public: 00351688061761
• 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 Catalogue Number: A2832-25
• Device Lot Number: 3142895
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2016
• 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
• Treatment: BUPIVACAINE