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

Catalog Number	FT19DN40NGE161N
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received that a smiths medical tracheostomy has a split in the curve of the flange.No further information reported.No patient injury resulted.
Additional Manufacturer Narrative
Device evaluation: two customized cuffed flextend devices were returned.Both of devices had a cut/split in the same area of the distal portion of the shaft.The devices appeared to have been heavily used.Customize devices are 200% inspected prior to packaging for cosmetic and functional requirements.The devices in this condition would not have passed the inspection process.A root cause could not be determined, ifu states under warnings to guard against product damage by avoiding contact with sharp edges.The customer reported condition was confirmed.Problem source is unknown.

• Brand Name: SMITHS MEDICAL CUSTOM 4.0 TTS 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: 8902597
• Report Number: 3012307300-2019-04046
• Device Sequence Number: 16651314
• Product Code: JOH
• UDI-Device Identifier: 15019517190618
• UDI-Public: 15019517190618
• Combination Product (Y/N): N
• 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): 09/08/2019

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 Catalogue Number: FT19DN40NGE161N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2019
• Supplement Date Received by Manufacturer: 08/23/2019
• Initial Report FDA Received Date: 08/16/2019
• Supplement Report FDA Received Date: 09/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1