MAUDE Adverse Event Report: SMITHS MEDICAL, ASD, INC. CUSTOM 4.0 FLEXTEND CUFFLESS TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	FU17LN40NSE956N
Medical Device Problem Code	Component Incompatible (1108)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/01/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the obturator in the custom 4.0 flextend cuffless tracheostomy tube was excessively short.The issue was noticed while trying to perform a trach change.No patient injury.

• Brand Name: CUSTOM 4.0 FLEXTEND CUFFLESS TRACHEOSTOMY TUBE
• 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: 7477170
• Report Number: 3012307300-2018-01252
• Device Sequence Number: 1768857
• Product Code: JOH
• UDI-Device Identifier: 15019517134278
• UDI-Public: 15019517134278
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/01/2018

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: Patient Family Member or Friend
• Device Expiration Date: 12/11/2022
• Device Catalogue Number: FU17LN40NSE956N
• Device Lot Number: SS012058
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2018
• Initial Report FDA Received Date: 05/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1