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

Catalog Number	49661C-25
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Awareness during Anaesthesia (1707)
Date of Event	11/21/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a patient's spinal anesthesia the use of an amp of marcaine (bupivacaine) packaged in a portex® spinal anesthesia tray did not work after a very short time.The patient started moving on the table.Marcaine is a local anesthetic.No adverse events were reported.
Additional Manufacturer Narrative
Reporter provided a non-smiths medical lot number of 662603a.No sample was received for investigation.An incoming records review for bupivacaine-marcaine lot number 662603a found no discrepancies or anomalies relevant to the complaint.Review of the specific device history record and sterilization records could not be performed without finished good lot number information.The anesthetics are supplied items and a notification was forwarded to the supplier.Based on available information and evidences, no product quality problem could be confirmed.Possible causes of lack of effect may be administration technique or patient anatomical variations, including pathological and psychological factors.
Event or Problem Description
It was additionally reported that the fault occurred after 25 minutes in use.General anesthesia was then used.

• 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: 7086212
• Report Number: 3012307300-2017-02505
• Device Sequence Number: 11042532
• Product Code: CAZ
• UDI-Device Identifier: 30351688047117
• UDI-Public: 30351688047117
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2018

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: Physician
• Device Catalogue Number: 49661C-25
• Device Lot Number: 662603A
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2017
• Supplement Date Received by Manufacturer: 12/07/2017
• Initial Report FDA Received Date: 12/06/2017
• Supplement Report FDA Received Date: 01/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1