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

Model Number 100/897/090CZ

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/24/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event 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.

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
• Type of Device: 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
• MDR Text Key: 222842516
• Report Number: 3012307300-2020-12625
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019315107214
• UDI-Public: 15019315107214
• Combination Product (y/n): N
• PMA/PMN Number: K083031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 100/897/090CZ
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/26/2020
• Initial Date FDA Received: 12/21/2020
• Supplement Dates Manufacturer Received: 01/14/2021
• Supplement Dates FDA Received: 02/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening