MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA; TRACHEOSTOMY

Model Number	67PFS30
Medical Device Problem Codes	Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Hypoxia (1918)
Date of Event	04/24/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Information received a smiths medical tracheostomy|silicone - bivona tubes neo/ped flextend cuff deflated as patient was able to pull the device out and extubate the airway.This in turn caused the oxygen saturation to fall below normal and an emergent tracheostomy change was performed.When the device was tested after incident, it was discovered the water stayed in the pilot balloon and not balloon itself.No other clinical injures were reported, as the issue was resolved with tracheostomy change out.
Additional Manufacturer Narrative
Other text: one bivona tracheostomy tube was returned for analysis in used conditions.No damage was detected upon visual inspection.The unit was filled with air too look for a functional problem; the cuff inflated but part of the cuff wasn?t uniformly.The cuff was manipulated and the whole cuff then inflated.The cuff was then inflated and deflated four times with no issue.The sample was observed for 10 seconds and the cuff did not deflate.The manufacturing process was reviewed and deemed adequate.The assembly process and training records were both reviewed; no discrepancies found.During the verification, 32 assemblies were reviewed to see the complete manufacturing process of the air way and balloon; no discrepancies found.Based on the evidence, the complaint was not confirmed as there was no fault found.

• Brand Name: BIVONA
• Common Device Name: TRACHEOSTOMY
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• MDR Report Key: 10110986
• Report Number: 3012307300-2020-05416
• Device Sequence Number: 19684819
• Product Code: JOH
• UDI-Device Identifier: 10351688518606
• UDI-Public: 10351688518606
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 09/14/2020

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: 03/27/2020
• Device Model Number: 67PFS30
• Device Catalogue Number: 67PFS30
• Device Lot Number: 3832010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/06/2020
• Supplement Date Received by Manufacturer: 08/16/2020
• Initial Report FDA Received Date: 06/02/2020
• Supplement Report FDA Received Date: 09/14/2020
• 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: 13 MO