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

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

Date of event, d4: catalog number, lot number, expiration date, udi section, h4: manufacture date, and g5: 510k are unknown, no information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported that the tracheostomy tube became dislodged with patient movement.Tracheostomy needed to be replaced.It was thought the tube was possibly too short.There was patient involved.It was reported to have "affects patient care but no injury".

Manufacturer Narrative

(b)(6).Evaluation codes: updated device evaluation: no product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.If the product is returned, the manufacturer will reopen this investigation.No device history report (dhr) review could be performed as no lot number has been provided to date.

Event Description

Additional information received via email.It was stated that the patient passed away in may.Medical assessment (b)(6) 2024: as reported the original complaints were related to the description of cuff deflation of a custom bivona tube.The manufacturer reached out several times since the initial report in (b)(6) 2023 with the last contact in (b)(6) 2023.It is reported that the parents did not want to answer any additional questions related to the event because the patient passed away in (b)(6) 2023.There is no information about the cause of the patient?s death and no further information can be obtained from the complainant.Lack of details regarding this clinical event precludes a comprehensive medical assessment.Based on a review of the events in this case the cumulative evidence of this incident, it appears to exclude the bivona custom tubes as the cause of the patient event because it was reported that the patient tolerated the tracheostomy tube uncuffed and deflated from (b)(6) 2023 until her passing.Patient death is reported.If additional information becomes available, this medical assessment will be further revised.

• Brand Name: BIVONA TRACHEOSTOMY TUBE
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17638411
• MDR Text Key: 322141828
• Report Number: 3012307300-2023-08441
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention