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

Model Number	FT14HN70NSC296N
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Muscle Weakness/Atrophy (1967)
Date of Event	10/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Operator of device: is the parent.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 trach was not holding fluid after two hours.Additionally, it was reported that "the trach is always tested before putting it in and it seemed to be fine with no leaks.They then deflated it to put in and then in over about 2-4hrs they noticed 2ml saline that was dumped in his lungs.The incident did cause harm.It made the patient not feel good for a couple of days, muscle strength totally gone, more secretions and gunk in his lungs.".
Additional Manufacturer Narrative
Other, other text: a device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual and functional testing were performed.During the functional and visual inspection, no leaks were detected.The investigation could not confirm a leak with the device.The root cause of the reported issue was not able to be determined.No corrective actions are planned at this time.Additional information in h6 and h10.

• Brand Name: BIVONA TUBES CUSTOM
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer (Section G): NULL; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15754950
• Report Number: 3012307300-2022-26905
• Device Sequence Number: 2868780
• Product Code: JOH
• UDI-Device Identifier: 10351688741066
• UDI-Public: 10351688741066
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2023

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: Other
• Device Model Number: FT14HN70NSC296N
• Device Catalogue Number: FT14HN70NSC296N
• Device Lot Number: GA030359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2022
• Supplement Date Received by Manufacturer: 01/19/2023
• Initial Report FDA Received Date: 11/08/2022
• Supplement Report FDA Received Date: 02/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Other
• Patient Age: 28 YR
• Patient Sex: Male
• Patient Weight: 40 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White