MAUDE Adverse Event Report: SMITHS MEDICAL ASD; INC. BIVONA® CUSTOMIZED FLEXTEND¿ TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	FT19GN40NSE226N
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/20/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received indicating that the connector to a smiths medical bivona® customized flextend¿ tracheostomy tube broke off.Subsequently, a trach tube change out was performed with no reported adverse patient effects.
Additional Manufacturer Narrative
One tracheostomy was returned with the iso connector separated from the device neckflange for evaluation.Ifu states: when connecting a breathing circuit or accessory to the connector, gently push the breathing circuit or accessory onto the connector using one hand and employing a slight twisting motion while stabilizing the base of the connector with the other hand.The connection security and ability to disconnect should then be checked by trial disconnection.Once the correct level of security has been established, the connection can then be remade using the same technique and force.Disconnection is best achieved with one hand holding the base of the connector and the other hand applying a twist and pull motion.Excessive force must not be applied when making the connection as this may result in difficulty in disconnecting the devices.In the event of difficulty disconnecting, the disconnect wedge provided should be used by forcing it between the flanges of the two connectors until they separate.The reported customer complaint has been confirmed during visual inspection of the device and the problem source has bee determined to be user interface.

• Brand Name: BIVONA® CUSTOMIZED FLEXTEND¿ 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: 9078397
• Report Number: 3012307300-2019-05012
• Device Sequence Number: 2477393
• Product Code: JOH
• UDI-Device Identifier: 15019517199963
• UDI-Public: 15019517199963
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 10/18/2019

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: FT19GN40NSE226N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2019
• Supplement Date Received by Manufacturer: 09/24/2019
• Initial Report FDA Received Date: 09/17/2019
• Supplement Report FDA Received Date: 10/18/2019
• 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