MAUDE Adverse Event Report: PORTEX

Model Number	Z210-16
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Ventilator Dependent (2395)
Date of Event	01/07/2021
Type of Reportable Event	Serious Injury
Event or Problem 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
• MDR Report Key: 11310094
• Report Number: 3012307300-2021-01130
• Device Sequence Number: 838054
• Product Code: BSY
• UDI-Device Identifier: 15019315046919
• UDI-Public: 15019315046919
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2021
• Initial Report FDA Received Date: 02/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening