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

Catalog Number	A4037-25
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Awareness during Anaesthesia (1707)
Date of Event	11/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
See mfr: 3012307300-2017-2536.
Event or Problem Description
It was reported that there was questionable potency (of marcaine) in face of a single pass easy placement of a spinal needle from a portex® spinal anesthesia tray.The patient had no motor block and required more intra-operative medications.This is consistent with bad marcaine.Marcaine is a local anesthetic.No adverse events were reported.
Additional Manufacturer Narrative
No sample was received for investigation.A review of the device history record found no discrepancies or anomalies relevant to the complaint.Assay testing was performed by the supplier prior to the release of bupivacaine lot number 77-398-ev.Review of the sterilization certificate for the tray lot number 3516651 revealed that the product was processed according to validated specification requirements and parameters.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 or psychological factors.

• 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: 7106100
• Report Number: 3012307300-2017-02535
• Device Sequence Number: 1298756
• Product Code: CAZ
• UDI-Device Identifier: 20351688080339
• UDI-Public: 20351688080339
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• 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 Expiration Date: 03/01/2019
• Device Catalogue Number: A4037-25
• Device Lot Number: 3516651
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2017
• Supplement Date Received by Manufacturer: 01/06/2018
• Initial Report FDA Received Date: 12/11/2017
• 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