MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA CUSTOM FLEXTEND TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	FP18JN40NSF111N
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Mechanical Jam (2983)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event : the date of event is noted to be either (b)(6) 2018 or (b)(6) 2018.Evaluation summary: one bivona custom flextend tracheostomy tube with an inline suction catheter was received for investigation.After visual inspection of the returned device, it was confirmed that the plastic swivel connector was broken and had snapped apart.The bottom lip of the swivel connector is broken and only a portion of it remains on the device.This defect is seen when excessive force has been applied to the connector or a tool other than the supplied disconnect wedge is used.Per device instruction warning statement, "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; refer to illustration a.Do not apply forces to the tube itself as this may result in tube damage which may compromise the airway." based on the evidence and inspection, it was determined the complaint allegation was confirmed.User interface was noted as the problem source.
Event or Problem Description
Information was received that "the colored end" of a smiths medical bivona custom flextend tracheostomy tube "broke off and was stuck inside the bollard elbow" while in use with a tracheostomy (trach) and ventilator dependent patient.Subsequently, the patient had an unscheduled trach change out.No clinical consequences to the patient were reported and the issue noted to be ongoing.

• Brand Name: BIVONA CUSTOM FLEXTEND 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: 8206404
• Report Number: 3012307300-2018-09080
• Device Sequence Number: 16661495
• Product Code: JOH
• UDI-Device Identifier: 15019517169027
• UDI-Public: 15019517169027
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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
• Report Date (Section B): 12/31/2018

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: 10/30/2023
• Device Model Number: FP18JN40NSF111N
• Device Catalogue Number: FP18JN40NSF111N
• Device Lot Number: DS021254
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2018
• Initial Report FDA Received Date: 12/31/2018
• 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