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

Catalog Number	67HA90
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/13/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received that while a smiths medical tracheostomy tube was in use, the patient experienced a loss of ventilation due to a cuff leak.The saline loss was seen in the bronchial tube visualized with fibroscopic column.No further adverse effects were reported.
Additional Manufacturer Narrative
Evaluation results: one bivona tracheostomy tube was received in used condition.The tracheostomy tube was returned for a loss of ventilation due to a cuff leak.The returned device was leak tested with 200 cc of air.The cuff was unable to fully inflate and immediately deflated as air escaped from a small hole/ scratch in the cuff.Upon visual inspection of the cuff, it was noted that there are two scratched areas next to the small hole on the cuff, perhaps caused by the device coming into contact with something sharp externally or potentially from hard cartilage internal to the patient.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.

• Brand Name: SMITHS MEDICAL BIVONA TUBES ADULT HYPERFLEX TTS
• 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: 8488775
• Report Number: 3012307300-2019-01779
• Device Sequence Number: 1884523
• Product Code: JOH
• UDI-Device Identifier: 15021312013825
• UDI-Public: 15021312013825
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K081440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2019

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 Expiration Date: 03/28/2021
• Device Catalogue Number: 67HA90
• Device Lot Number: 3159593
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2019
• Supplement Date Received by Manufacturer: 08/26/2019
• Initial Report FDA Received Date: 04/05/2019
• Supplement Report FDA Received Date: 09/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR