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

Catalog Number	NLD-15545C-21
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional 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 # 54438ev revealed no discrepancies that may have contributed to a complaint of this nature.All testing was performed and was within specification requirements.Retained file samples for the lot in question was tested for potency and found to be within 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 or Problem Description
It was reported that during use of a portex® spinal anesthesia tray bupivacaine failed.

• Brand Name: PORTEX® SPINAL ANESTHESIA TRAY
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7507950
• Report Number: 3012307300-2018-10139
• Device Sequence Number: 19158839
• Product Code: CAZ
• UDI-Device Identifier: 20351688078602
• UDI-Public: 20351688078602
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2017
• Device Catalogue Number: NLD-15545C-21
• Device Lot Number: 3079027
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2016
• Initial Report FDA Received Date: 05/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BUPIVACAINE