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

Catalog Number	ST17GN80NSC903N
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the water was not holding and something was wrong with the cuff.The event occurred before patient use, and no patient harm/adverse event was reported.
Additional Manufacturer Narrative
D4.Lot number, expiration date, and h4.Manufacture date are unknown; no information has been provided to date.D4.Primary udi number: the primary di# has been used as the lot/serial information is unknown.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.
Additional Manufacturer Narrative
Investigation summary: the affected device was returned for evaluation.Visual inspection by the unaided eye and under normal plant lighting of the returned device did not identify a defect.Using a syringe,10 cc of water was inserted into the inflation system.The device was allowed to rest for 4 hours; the cuff remained inflated; no change in volume was detected.The investigation could not confirm the alleged defect; no leaks were detected with the device.A device history record could not be completed as no lot number was received.
Event or Problem Description
It was reported that the water was not holding and something was wrong with the cuff.The event occurred before patient use, and no patient harm/adverse event was reported.

• Brand Name: BIVONA CUSTOM TRACHEOSTOMY TUBE
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 201 west queen st; southington IN 06489
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19973580
• Report Number: 1219611-2024-00035
• Device Sequence Number: 7057373
• Product Code: JOH
• UDI-Device Identifier: 15019517117233
• UDI-Public: (01)
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: ST17GN80NSC903N
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/12/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2024
• Supplement Date Received by Manufacturer: 08/26/2024
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 09/25/2024
• 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
• Patient Age: 30 YR
• Patient Sex: Unknown