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

Catalog Number	75HA70
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Failure to Deflate (4060)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	04/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3: device not returned to manufacturer.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 or Problem Description
It was reported that the tracheostomy tube was placed but was not long enough for the patient.The doctor had to try to aspirate the air out and was not able to get the trach tube to deflate.On several attempts it finally deflated but the patient ended up intubated during the time being due to not being able to ventilate the patient.The patient has significant tracheal stenosis.The doctor finally was able to remove the trach and place a new trach.The patient was returned to the icu on the ventilator.
Additional Manufacturer Narrative
Investigation summary: 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.A review of the device history record (dhr) shows there were no observations or nonconformities recorded, during manufacture to suggest an issue of this nature would occur with this lot of products.

• Brand Name: BIVONA TRACHEOSTOMY TUBE, ADULT HYPERFLEX
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 w 23rd ave; gary IN 46406
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19510147
• Report Number: 1824231-2024-00052
• Device Sequence Number: 14316609
• Product Code: JOH
• UDI-Device Identifier: 15021312013849
• UDI-Public: (01)15021312013849(17)261028(10)4185529
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K081440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 75HA70
• Device Lot Number: 4185529
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2024
• Supplement Date Received by Manufacturer: 06/12/2024
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 07/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/16/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: VENTILATOR
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic
• Patient Race: White