MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA CUSTOM 6.0 A/C FLEXTEND NS TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	FA15CN60NGF124N
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Item and lot number originally was unknown, but was provided upon product receipt.
Event or Problem Description
Information was received that a smiths medical bivona custom 6.0 a/c flextend ns tracheostomy tube came apart between the hub and the silicone.The reporter stated the device had been processed two times.Subsequently, a tube change was required by a rt.No adverse patient effects were reported.
Additional Manufacturer Narrative
Evaluation results: one customized cuff device was returned with the plastic iso connector separating from the silicone hub portion of the device.A visual observation showed the plastic mechanical locking features (i.E., ribs) that bond the plastic to the silicone were cracked/damaged.The investigation did not reveal any intrinsic manufacturing defects with the returned device.The damage to the connector occurred after the devices were put in use.It is likely that an accessory or ventilator was seated too far onto the connector, which did not leave space or a gap for the disconnect wedge to be inserted per the design.Using the disconnect wedge or other tool on the silicone portion of the connector to remove an accessory or ventilator cracked / broke the ribs that secure the connector in place.The instruction for use, states that under warnings to always hold the base of the 15mm connector when disconnecting.If difficulty is experienced when disconnecting, utilize the disconnect wedge provided by inserting the thin end between the connectors and pushing to force them apart.Do not apply forces to the tube itself as this may result in tube damage which may compromise the airway.Under set up and use, the instruction for use states that in the event of difficulty disconnecting the accessory components from the tracheostomy tube's 15mm iso connector, the disconnect wedge provided should be used by forcing it between the flanges of the two connectors until they separate.No manufacturing defects or adverse trends have been identified related to this issue.No corrective actions are planned at this time.Smiths medical regularly analyzes complaint data and trends and will take further actions accordingly.

• Brand Name: BIVONA CUSTOM 6.0 A/C FLEXTEND NS 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: 9460632
• Report Number: 3012307300-2019-06663
• Device Sequence Number: 14221167
• Product Code: JOH
• UDI-Device Identifier: 10351688822871
• UDI-Public: 10351688822871
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• 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): 02/13/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/17/2024
• Device Model Number: FA15CN60NGF124N
• Device Catalogue Number: FA15CN60NGF124N
• Device Lot Number: DS032476
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2019
• Supplement Date Received by Manufacturer: 01/14/2020
• Initial Report FDA Received Date: 12/12/2019
• Supplement Report FDA Received Date: 02/13/2020
• 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: Required Intervention