MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX; TRACHEOBRONCHIAL SUCTION CATHETER.

Model Number Z110N-14

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Event 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
• Type of Device: TRACHEOBRONCHIAL SUCTION CATHETER.
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• MDR Report Key: 11244257
• MDR Text Key: 229132323
• Report Number: 3012307300-2021-00708
• Device Sequence Number: 1
• Product Code: BSY
• UDI-Device Identifier: 15019315058868
• UDI-Public: 15019315058868
• Combination Product (y/n): N
• PMA/PMN Number: K923559
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial
• Report Date: 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: Z110N-14
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/29/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention