MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC FLEXTEND; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	FT18AN35NGF047S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/01/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 20 minutes after a tracheostomy tube change was performed, the connection for the ventilator broke off the tracheostomy tube.No patient injury or complications were reported in relation to this event.The issue was described as being resolved.
Event or Problem Description
Investigation not completed on a smiths medical tracheostomy flextend.No product was turned.
Additional Manufacturer Narrative
No product was returned for investigation.

• Brand Name: FLEXTEND
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 9367567
• Report Number: 3012307300-2019-06638
• Device Sequence Number: 19392676
• Product Code: JOH
• UDI-Device Identifier: 15019517137484
• UDI-Public: 15019517137484
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• 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): 04/10/2020

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 Expiration Date: 10/16/2024
• Device Model Number: FT18AN35NGF047S
• Device Catalogue Number: FT18AN35NGF047S
• Device Lot Number: DS032346
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2019
• Supplement Date Received by Manufacturer: 11/08/2019
• Initial Report FDA Received Date: 11/24/2019
• Supplement Report FDA Received Date: 04/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 2 YR