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

Catalog Number A4037-25

Device Problem Degraded (1153)

Patient Problem Awareness during Anaesthesia (1707)

Event Date 11/29/2017

Event Type  malfunction  

Manufacturer Narrative

See mfr: 3012307300-2017-2536.

Event 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.

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
• 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 NH 03431 0724
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7106100
• MDR Text Key: 94491759
• Report Number: 3012307300-2017-02535
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 20351688080339
• UDI-Public: 20351688080339
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/01/2019
• Device Catalogue Number: A4037-25
• Device Lot Number: 3516651
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2017
• 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