MAUDE Adverse Event Report: SMITHS MEDICAL PORTEX SPINAL TRAY 2ML

Model Number ND-15597-20

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 01/21/2015

Event Type  malfunction  

Event Description

The lidocaine and/or bupivicaine injected by crna was ineffective as was indicated during c-section procedure.Anesthesia had to be re administered during the procedure.Reason for use: numbing agent bupivicaine 2ml, intramuscular.

• Brand Name: PORTEX SPINAL TRAY 2ML
• Type of Device: PORTEX SPINAL TRAY 2ML
• Manufacturer (Section D): SMITHS MEDICAL; keene NH 03431
• MDR Report Key: 4465818
• MDR Text Key: 21092389
• Report Number: MW5040425
• Device Sequence Number: 1
• Product Code: CAZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/01/2015
• Device Model Number: ND-15597-20
• Device Catalogue Number: ND-15597-20
• Device Lot Number: 2870116
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: LIDOCAINE; BUPIVICAINE, 2ML
• Patient Age: 23 YR
• Patient Weight: 75