MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX

Model Number Z210-16

Device Problem Gas/Air Leak (2946)

Patient Problem Ventilator Dependent (2395)

Event Date 01/07/2021

Event Type  Injury  

Event Description

Information was received indicating that the portex catheters suction pro leaked.It was not possible to identify the location of the leak, but an audible leak was noted.The consequences was depressurization with a high peep in a protonated patient.

• Brand Name: PORTEX
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• MDR Report Key: 11310094
• MDR Text Key: 231299986
• Report Number: 3012307300-2021-01130
• Device Sequence Number: 1
• Product Code: BSY
• UDI-Device Identifier: 15019315046919
• UDI-Public: 15019315046919
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial
• Report Date: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2023
• Device Model Number: Z210-16
• Device Lot Number: 3975210
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening