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

Catalog Number 49663C-25

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Review of device history records and incoming records found no discrepancies or anomalies relevant to the complaint.The anesthetics are supplied items and the complaint notification was forwarded to the supplier.Records analysis was performed by the supplier for bupivacaine-marcaine lot #'s 641403a, epinephrine lot # 631353a, lidocaine lot #'s 642703a, 640603a, 641553a and confirmed that the reported lots continue to meet all specifications.Possible causes of lack of effect may be administration technique or patient anatomical variations, including pathological or psychological factors.

Event Description

It was reported that the bupivacaine contained in the portex® spinal anesthesia tray was ineffective.No patient death or serious injury was reported in connection with this incident.

• Brand Name: PORTEX® SPINAL ANESTHESIA TRAYS
• 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 03431 0724
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7508169
• MDR Text Key: 108165470
• Report Number: 3012307300-2018-10219
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00351688057788
• UDI-Public: 00351688057788
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: No Information
• Device Catalogue Number: 49663C-25
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/11/2018
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1