MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC BIVONA® CUSTOM 7.0MM FOME-CUF® STANDARD TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	CM3004N
Medical Device Problem Codes	Air Leak (1008); Inadequacy of Device Shape and/or Size (1583); Infusion or Flow Problem (2964)
Health Effect - Clinical Codes	Hypoventilation (1916); Lethargy (2560)
Date of Event	01/24/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is currently being evaluated; the manufacturer will file a follow-up report detailing the results of the evaluation once it is completed.Device evaluation in progress.
Event or Problem Description
It was reported that during patient use of the bivona® custom 7.0mm fome-cuf® standard tracheostomy tube, the tracheostomy tube was leaking air around the bottom cuff.The reported tracheostomy tube had two device cuffs, the top cuff was located at the stoma and the bottom cuff was located at the distal end of the shaft.According to the report, the device was processed on (b)(6) and placed into the patient's trachea on (b)(6).It was reported that during placement the device inserted into the patient's stoma easier than normal and with less resistance.It was reported that the cuff of the device was too small.After three days patient use, three of the patient's nurses determined that the tracheostomy tube was not maintaining a proper seal in all bodily positions.Additionally, the nurses noted a ventilation leak coming out patient's stoma.On (b)(6), the tracheostomy tube was replaced with the patient previous device.The patient experienced lethargy and their lungs became atelectasis due to the reported event.It was reported that the event was resolved after the tracheostomy tube change.No permanent adverse effect to patient was reported.
Additional Manufacturer Narrative
Two bivona® 7.0mm custom tracheostomy tube were returned for investigation.Visual inspection of the devices revealed that both devices were in like-new condition with no signs of contamination, tears, holes, or rips.The devices were inspected and the cuffs on both devices were measured using a digital caliper.The two cuffs on both devices were found to be within specification.During functional testing, the two device cuffs located on each tracheostomy tube were inflated with 20cc's of air and the devices were submerged under water.It was found that both cuffs on the devices inflated and held air with no leaks present.Investigation was unable to confirm the reported issue and found that both devices functioned as intended.

• Brand Name: BIVONA® CUSTOM 7.0MM FOME-CUF® STANDARD 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: 6367891
• Report Number: 3012307300-2017-00579
• Device Sequence Number: 19138994
• Product Code: JOH
• UDI-Device Identifier: 15019517019902
• UDI-Public: 15019517019902
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2017

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: Health Professional
• Device Expiration Date: 01/13/2022
• Device Catalogue Number: CM3004N
• Device Lot Number: DS001588
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/02/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/01/2017
• Supplement Report FDA Received Date: 04/22/2017
• 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: 25 YR