PORTEX 100/199/075

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-07-23 for PORTEX 100/199/075 manufactured by Smiths Medical Asd, Inc.

Event Text Entries

[152011434] It was reported that the customer identified a hole in the portex endotracheal tube after intubation. An emergent replacement was performed. No patient injury or complications were reported in relation to this event.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3012307300-2019-03697
• MDR Report Key: 8819633
• Report Source: USER FACILITY
• Date Received: 2019-07-23
• Date of Report: 2019-09-11
• Date Mfgr Received: 2019-08-12
• Date Added to Maude: 2019-07-23
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• 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
• Manufacturer Contact: DAVE HALVERSON
• Manufacturer Street: 6000 NATHAN LANE NORTH
• Manufacturer City: MINNEAPOLIS MN 55442
• Manufacturer Country: US
• Manufacturer Postal: 55442
• Manufacturer G1: SMITHS MEDICAL INTERNATIONAL LTD
• Manufacturer Street: BOUNDARY ROAD
• Manufacturer City: HYTHE,
• Manufacturer Country: UK
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: PORTEX
• Generic Name: TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)
• Product Code: CBI
• Date Received: 2019-07-23
• Catalog Number: 100/199/075
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SMITHS MEDICAL ASD, INC
• Manufacturer Address: 6000 NATHAN LANE NORTH MINNEAPOLIS MN 55442 US 55442

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2019-07-23