MAUDE Adverse Event Report: PORTEX; TRACHEOBRONCHIAL SUCTION CATHETER.

Model Number	Z110N-14
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received indicating that during suctioning of a covid patient, the portex catheters suction broke in two pieces.A replacement of the ventilator circuit and manual hand ventilation in meantime was performed.There was no harm to the patient.

• Brand Name: PORTEX
• Common Device Name: TRACHEOBRONCHIAL SUCTION CATHETER.
• MDR Report Key: 11244257
• Report Number: 3012307300-2021-00708
• Device Sequence Number: 17034846
• Product Code: BSY
• UDI-Device Identifier: 15019315058868
• UDI-Public: 15019315058868
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K923559
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/28/2021

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: No Information
• Device Model Number: Z110N-14
• Device Lot Number: UNKNOWN
• 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: 12/29/2020
• Initial Report FDA Received Date: 01/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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; Required Intervention