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

Catalog Number	ZA24FN85ZSZ237N
Medical Device Problem Codes	Deflation Problem (1149); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2024
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that the device would not hold air in the cuff.The patient was awakened by a leak when the cuff was low and was able to talk.They filled the cuff and 6ml of air leaked out in less than 20 minutes.There was medical intervention required, the trach needed to be changed.There was patient involvement but no patient harm reported.
Additional Manufacturer Narrative
Investigation summary: the affected device was returned for evaluation.Visual inspection by the unaided eye under normal plant lighting of the returned device did not identify any defects or anomalies.Using a syringe, the air was evacuated from the foam stoma cuff and the red plug sealed.The stoma cuff remained contracted; no leaks were detected in the foam cuff.Using a syringe, 10 cc of air was inserted into the distal air cuff.The cuff inflated and remained inflated.The device was allowed to rest for 6 six hours with the air cuff inflated and the foam cuff deflated; no changes were observed after six hours.No leaks were detected.Complaint is not confirmed.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 CUSTOM 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: 19973570
• Report Number: 1824231-2024-00072
• Device Sequence Number: 20573901
• Product Code: JOH
• UDI-Device Identifier: 15019517390766
• UDI-Public: (01)15019517390766(17)290712(10)GB023492
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2024

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: ZA24FN85ZSZ237N
• Device Lot Number: GB023492
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/01/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2024
• Supplement Date Received by Manufacturer: 08/26/2024
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 28 YR
• Patient Sex: Unknown