MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX BIVONA TTS (TIGHT-TO-SHAFT) TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	67SP055
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/30/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received that a smiths medical portex bivona tts (tight-to-shaft) tracheostomy tube cuff leaked immediately upon use.Subsequently, a tracheostomy (trach) change out was required.No adverse patient effects were reported.
Additional Manufacturer Narrative
Device evaluation: one bivona tracheostomy sample was received in used condition without the original packaging.Immediate visual inspection detected hole in the inflation line.A leak and inflation test was completed and leaks was confirmed where the hole was detected.The cuff assembly operation and inflation line assembly were reviewed to ensure the air way and balloon are manufactured correctly with no discrepancies.Samples were audited during thirty two (32) units finding no issues.A review of the manufacturing process was conducted and was considered adequate and correct.In attempt to reproduce the failure mode, the unit was cut using tweezers and a hole in the inflation line was observed.Based on the evidence and testing, the complaint was confirmed.The most likely contributing factors to the issue were noted to be the following: the unit was damaged during the use of the tweezers after cleaning or the product was damaged after leaving the smiths facility.Manufacturing was noted as the problem source.

• Brand Name: PORTEX BIVONA TTS (TIGHT-TO-SHAFT) 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: 8145350
• Report Number: 3012307300-2018-08649
• Device Sequence Number: 1961701
• Product Code: JOH
• UDI-Device Identifier: 15021312000757
• UDI-Public: 15021312000757
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K914088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2019

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
• Operator of Device: No Information
• Device Model Number: 67SP055
• Device Catalogue Number: 67SP055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2018
• Supplement Date Received by Manufacturer: 02/26/2019
• Initial Report FDA Received Date: 12/09/2018
• Supplement Report FDA Received Date: 03/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 27 YR