MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA CUSTOM 6.0 TTS HYPERFLEX TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	HT14KS60NSC287S
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation: one bivona device was returned for investigation.A visual inspection under normal lighting revealed that the valve in the pilot balloon was nested too far into the pilot balloon.A syringe was connected to the valve and while holding the pilot balloon the valve was maneuvered to the correct positioning in the pilot balloon.Next, the inflation line was checked by inflating the cuff.No leak was observed.The investigation determined that the device did meet manufacturing specification.Products are subject to visual and functional inspection before distribution.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.For this evaluation, the complaint was confirmed, but there was no manufacturing defect or event problem source identified.
Event or Problem Description
Information was received that a smiths medical bivona custom 6.0 tts hyperflex tracheostomy tube was placed with a patient on (b)(6) 2019.On (b)(6) 2019 it was reported that the pilot port broke, even though the balloon "still seems to hold air".Subsequently, an emergency tube change out was required and the patient recovered.There were no adverse patient effects.

• Brand Name: BIVONA CUSTOM 6.0 TTS HYPERFLEX 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: 9153996
• Report Number: 3012307300-2019-05199
• Device Sequence Number: 14185173
• Product Code: JOH
• UDI-Device Identifier: 15019517022605
• UDI-Public: 15019517022605
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/03/2019

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: Lay User/Patient
• Device Expiration Date: 11/29/2023
• Device Model Number: HT14KS60NSC287S
• Device Catalogue Number: HT14KS60NSC287S
• Device Lot Number: DS021684
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2019
• Initial Report FDA Received Date: 10/03/2019
• 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: Life Threatening; Required Intervention
• Patient Age: 32 YR
• Patient Weight: 57