PORTEX * 3717C-20

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-05-01 for PORTEX * 3717C-20 manufactured by Smiths Medical Asd, Inc..

Event Text Entries

[17384028] Anesthesiologist gave spinal anesthesia with no problem, then noted that the anesthesia was not effective. The patient then underwent general anesthesia. The patient tolerated the procedure well, and there were no complications. All spinal kits with this same lot number were pulled from the shelves, and the distributing company was notified as well.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3788168
• MDR Report Key: 3788168
• Date Received: 2014-05-01
• Date of Report: 2014-05-01
• Date of Event: 2014-05-01
• Report Date: 2014-05-01
• Date Added to Maude: 2014-05-05
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: PORTEX
• Generic Name: ANESTHESIA KIT SPINAL
• Product Code: OFU
• Date Received: 2014-05-01
• Model Number: *
• Catalog Number: 3717C-20
• Lot Number: 2647136
• ID Number: *
• Operator: PHYSICIAN
• Device Availability: Y
• Device Age: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SMITHS MEDICAL ASD, INC.
• Manufacturer Address: 1265 GREY FOX RD ST.PAUL MN 55112 US 55112

Device Sequence Number: 2

• Brand Name: *
• Generic Name: *
• Product Code: ---
• Date Received: 2014-05-01
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Device Age: *
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: *
• Manufacturer Address: * * * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2014-05-01