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

Model Number NEPI-NLD-15583C-21

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/25/2019

Event Type  malfunction  

Manufacturer Narrative

Possible lot numbers: 3702073 or 37020272.

Event Description

Information was received that the bupivicaine in a smiths medical portex spinal anesthesia tray did not work during a procedure.It was noted that the "patient didn't have any complication and didn't have any anatomical issue that lead to spinal insertion complication.Due to complications from the kit not working, the patient was forced to receive general anesthesia".

• 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
• MDR Report Key: 8446738
• MDR Text Key: 139681101
• Report Number: 3012307300-2019-01513
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 35019517115684
• UDI-Public: 35019517115684
• 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,other,use
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 03/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEPI-NLD-15583C-21
• Device Catalogue Number: NEPI-NLD-15583C-21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1