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

Model Number FT19JN40NGE162N

Device Problems Leak/Splash (1354); Material Puncture/Hole (1504)

Patient Problem Insufficient Information (4580)

Event Type  Death  

Event Description

It was reported that right after opening and using a custom trach, there were issues with the cuff not retaining water.While in the hospital it was discovered that there was a hole in the cuff.It was noted that the patient can "tolerate the trach uncuffed/deflated".The reporter mentioned that this occurred another time as well.No adverse effects reported.

Manufacturer Narrative

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

Additional information received via email.It was stated that the patient passed away in (b)(6) 2023.Medical assessment received (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.

Manufacturer Narrative

B1, b2: month and year have been provided, day is unknown., b5, h1 and h6 health impact; updated.D3, g1,2 email is: (b)(6).No product or photos were returned therefore no device analysis could be completed.A device history record (dhr) review could not be performed as the lot number was unknown.If the product is returned the manufacturer will re-open the complaint for further device analysis.

• Brand Name: BIVONA CUSTOMIZED TRACHEOSTOMY TUBES
• 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: 16781566
• MDR Text Key: 314028812
• Report Number: 3012307300-2023-04351
• Device Sequence Number: 1
• Product Code: JOH
• UDI-Device Identifier: 15019517221312
• UDI-Public: 15019517221312
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K923878
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: FT19JN40NGE162N
• Device Catalogue Number: FT19JN40NGE162N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/18/2023
• 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): Death