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

Model Number FT21GN35NGE965N

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 05/25/2023

Event Type  Injury  

Manufacturer Narrative

Lot number, expiration date and h4: device manufacture date is 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 upon placing the trach into patient and attempting to fill pilot balloon saline leaked where the balloon tubing connects to the trach.No adverse effects reported.

Event Description

Additional information was received: the trach was in a nicu patient, and the cuff had a micro leak soon after placed in patient.They changed it out to the only spare trach.While awaiting the new one to arrive they had to change out.They clean the bivona and once dry they placed it back in the infant.They did remember which patient this happened to know that it has been this long.They had numerous trach babies in the past 8 months.They recently had another with a leak.

Manufacturer Narrative

Additional information: b1, b2, b5, h6 - health impact codes device evaluation: h6 - evaluation codes updated.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 complaint for further investigation.No lot number was provided, therefore no device history report (dhr) review could be performed.

• Brand Name: BIVONA
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17113006
• MDR Text Key: 317079179
• Report Number: 3012307300-2023-06174
• Device Sequence Number: 1
• Product Code: JOH
• UDI-Device Identifier: 15019517274011
• UDI-Public: 15019517274011
• 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: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FT21GN35NGE965N
• Device Catalogue Number: FT21GN35NGE965N
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/20/2023
• 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