MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX; TRACHEOSTOMY

Model Number	8.5
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/01/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Information received that a smiths medical tracheostomy|pvc - portex tubes bluselect during precheck had no anomaly in the product was observed.The customer started to use it.And after a couple of days, when he checked the cuff's air pressure, he noticed the pilot balloon was detached.No patient injury was reported.
Additional Manufacturer Narrative
Device evaluation results: one used and decontaminated portex bluselect tracheostomy was returned in a plastic bag for investigation.Under visual inspection the investigator noticed that the pilot balloon was detached from the inflation line, and that the inflation line was also shorter than it should have been.The length of the inflation line should have been 326 ? 334 mm, however the returned inflation line was approximately 170 mm long.At the end of the inflation line there was also a visible clear cut that was caused by a sharp tool.This led to a leak in the inflation system.Cuff inflation was not maintained as a result causing insufficient seal within the trachea.The pilot balloon was also detached for an unknown reason.The customer reported product problems were confirmed.A definitive root cause(s) was not established.

• Brand Name: PORTEX
• Common Device Name: TRACHEOSTOMY
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• MDR Report Key: 10613524
• Report Number: 3012307300-2020-10014
• Device Sequence Number: 2719316
• Product Code: BTO
• UDI-Device Identifier: 15019517076233
• UDI-Public: 15019517076233
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 8.5
• Device Catalogue Number: 101/870/085CZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/07/2020
• Supplement Date Received by Manufacturer: 10/22/2020
• Initial Report FDA Received Date: 10/01/2020
• Supplement Report FDA Received Date: 11/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1