MAUDE Adverse Event Report: SMITHS MEDICAL ASD; INC. BIVONA® ADULT TTS¿ HYPERFLEX¿ TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	67HA80
Medical Device Problem Codes	Leak/Splash (1354); Material Puncture/Hole (1504); Scratched Material (3020)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
One bivona® adult tts¿ hyperflex¿ tracheostomy tube was returned for analysis.Visual inspection revealed a black piece of tape was found on the cuff and two marks on the cuff.The cuff was then inflated with air but was observed to deflate within one minute.The device was then put through leak testing; the leak was found to be leaking near the right side of the tape.Magnification was used to inspect the cuff; abrasions were found on the cuff.Based on the evidence the complaint was confirmed.The root cause was found to be user interface as the abrasions were likely due to repossessing.
Event or Problem Description
Information was received indicating that 3 days following placement of a smiths medical bivona® adult tts¿ hyperflex¿ tracheostomy tube the ventilator was alarming and 3mls of water was remaining in the cuff.It was reported that initially 8mls of sterile water was used to inflate the cuff.The physician had decided to use this type of trach as the patient had a tracheomalacia.Subsequently, a trach tube change out was performed.A pinhole on the cuff was found following removal.There were no reported adverse patient effects.

• Brand Name: BIVONA® ADULT TTS¿ HYPERFLEX¿ TRACHEOSTOMY TUBE
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis, MN 55442
• MDR Report Key: 9306192
• Report Number: 3012307300-2019-06310
• Device Sequence Number: 2172099
• Product Code: JOH
• UDI-Device Identifier: 15021312013818
• UDI-Public: 15021312013818
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K081440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/11/2019

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?: Yes
• Operator of Device: No Information
• Device Expiration Date: 05/03/2024
• Device Catalogue Number: 67HA80
• Device Lot Number: 3789980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2019
• Initial Report FDA Received Date: 11/11/2019
• 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