MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA CUSTOM 6.0 TIGHT TO SHAFT FLEXTEND TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	XT23GS60NGC212N
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3: reason device not evaluated by mfg: other; device was 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 during trach care, an overfill of the train balloon was noted and while extracting water from the pilot balloon, it had more resistance than normal and was slow to extract.The balloon would be completely compressed and refill after waiting.Filling water in pilot balloon had resistance and pilot balloon was noted to be lopsided during fill and trach itself was lopsided.Both were manipulated to form symmetrical shape.There was medical intervention required, and the outcome of the injury (bleeding from airway) was resolved by on (b)(6) 2024.The issue was resolved by changing out the trach for visible testing.There was patient involvement, with injury and no death event reported.
Additional Manufacturer Narrative
One device was returned for analysis.Device is visually free from defects.During leak testing, it was observed that the cuff inflated asymmetrically.From the measurements taken, asymmetrical inflation is observed and exceeds acceptance limits.The reported defect is observed and can be traced to the manufacturing process.This information is documented and will be tracked for trending purposes.

• Brand Name: BIVONA CUSTOM 6.0 TIGHT TO SHAFT FLEXTEND TRACHEOSTOMY TUBE
• 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 ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20651360
• Report Number: 1824231-2024-00092
• Device Sequence Number: 8219070
• Product Code: JOH
• UDI-Device Identifier: 15019517393491
• UDI-Public: (01)15019517393491(17)290815(10)GB025055
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2026

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: XT23GS60NGC212N
• Device Lot Number: GB025055
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/28/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2024
• Supplement Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 11/11/2024
• Supplement Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2024
• 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: 6.0 CUSTOM BIVONA/10MM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 18 YR
• Patient Sex: Female
• Patient Weight: 30 KG
• Patient Race: Native Hawaiian Or Other Pacific Islander