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

Catalog Number 49661C-25

Device Problem Degraded (1153)

Patient Problem Awareness during Anaesthesia (1707)

Event Date 11/21/2017

Event Type  malfunction  

Event 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.

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 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
• 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: 7086212
• MDR Text Key: 93821867
• Report Number: 3012307300-2017-02505
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 30351688047117
• UDI-Public: 30351688047117
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• 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: 12/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 49661C-25
• Device Lot Number: 662603A
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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