MAUDE Adverse Event Report: PORTEX; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number	101/860/085CZ
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/01/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the device was in use for 10 days when the inflation line became detached from the rest of the device.No adverse effects reported.
Additional Manufacturer Narrative
Investigation completed on a smiths medical tracheostomy|pvc - portex tubes bluselect sample p/n 100/860/085z evaluated.Visual inspection revealed pilot balloon detached from tube as event was confirmed with inspection 12"- 16".No other device analysis was done as event was confirmed.All mitigations on placed were verified and it was confirmed has been executing according, therefore no corrective actions could be implemented, it will be continue monitoring this failure condition in this product for threshold or escalation.
Event or Problem Description
Investigation completed and summary in h 10.

• Brand Name: PORTEX
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• MDR Report Key: 10806588
• Report Number: 3012307300-2020-11242
• Device Sequence Number: 3349046
• Product Code: BTO
• UDI-Device Identifier: 15019517076165
• UDI-Public: 15019517076165
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2021

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: 101/860/085CZ
• Device Catalogue Number: 101/860/085CZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/09/2020
• Supplement Date Received by Manufacturer: 03/07/2021
• Initial Report FDA Received Date: 11/08/2020
• Supplement Report FDA Received Date: 04/06/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Required Intervention