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

Model Number	100/897/090CZ
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
Information was received indicating that a smiths medical uni perc size 9 adjustable flange tracheostomy was inserted in patient on (b)(6) 2020.On (b)(6) 2020 the connector (white section that ventilator circuit attaches to) separated from the tube.As a result tracheostomy change required.There were no reported adverse events.
Additional Manufacturer Narrative
Other text: one portex tube was returned for analysis.Under visual inspection, it was noted that the white connector is separated from tracheostomy tube as described by customer.There was not any other defect found on returned sample.Connectors are manually bonded with tracheostomy tube as per the manufacturing procedure by the help of the solvent.Within this manufacturing process there are also implemented several quality checks which contains visual and functional inspection.The returned sample was inspected under magnification and presence of solvent was confirmed.There are solvent spots on the connector which indicates that solvent process happened.Complaint history was checked and no trend of confirmed customer complaints was identified.Therefore this issue is considered to be isolated incident with unknown root cause.

• Brand Name: PORTEX
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; olomoucka 306; hranice 1, mesto 753 0 1; EZ 753 01
• MDR Report Key: 11048180
• Report Number: 3012307300-2020-12625
• Device Sequence Number: 19091110
• Product Code: BTO
• UDI-Device Identifier: 15019315107214
• UDI-Public: 15019315107214
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K083031
• 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,Followup
• Report Date (Section B): 02/11/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 100/897/090CZ
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/26/2020
• Supplement Date Received by Manufacturer: 01/14/2021
• Initial Report FDA Received Date: 12/21/2020
• Supplement Report FDA Received Date: 02/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening