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

Catalog Number	ZT17LN80NSC098S
Medical Device Problem Codes	Fluid/Blood Leak (1250); Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/24/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a flextend¿ tts¿ tracheostomy tube was not holding saline.The defect was discovered after use with a patient.The product issue did not cause patient injury.
Additional Manufacturer Narrative
Two smiths medical portex bivona flextend¿ tts¿ tracheostomy tubes were returned for analysis.Visual exam performed showing no flaws.Leak tests were performed indicating that a small leak was noted in one of the tracheostomy (trach) tubes.The amount of adhesive surrounding the airway line at the neck-flange junction was noted to be adequate.Based on the evidence, the root cause of the leak was unable to be determined if it was manufacturing related or excessive force that would have been applied to the airway line.

• Brand Name: FLEXTEND¿ TTS¿ 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: 7448709
• Report Number: 3012307300-2018-01222
• Device Sequence Number: 1769116
• Product Code: JOH
• UDI-Device Identifier: 15019517136029
• UDI-Public: 15019517136029
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 05/30/2018

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: Health Professional
• Device Expiration Date: 01/25/2023
• Device Catalogue Number: ZT17LN80NSC098S
• Device Lot Number: DS012411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2018
• Supplement Date Received by Manufacturer: 05/02/2018
• Initial Report FDA Received Date: 04/20/2018
• Supplement Report FDA Received Date: 05/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 22 YR