MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA CUSTOM 5.0 FLEXTEND TIGHT TO SHAFT; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	FT18EN50NGF889N
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Codes	Pneumonia (2011); Choking (2464)
Date of Event	06/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that water goes into the port but will not inflate the cuff.There was a patient involvement and patient harm recorded.The operator of the device was the lay user or patient and it did occur at the patient's home.The continued leaking cuff caused pneumonia and chocking.Hospitalization for one week on antibiotics but the most recent was an emergency trach change.The outcome of the event has been reported as resolved.
Additional Manufacturer Narrative
B3: date of event is unknown, no information has been provided to date.H3 - other: device has not been returned to date.Device evaluation: no product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be 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.If the product is returned, the manufacturer will reopen this complaint for further investigation.

• Brand Name: BIVONA CUSTOM 5.0 FLEXTEND TIGHT TO SHAFT
• 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: 18848162
• Report Number: 1824231-2024-00017
• Device Sequence Number: 7214596
• Product Code: JOH
• UDI-Device Identifier: 15019517153224
• UDI-Public: (01)15019517153224(17)280502(10)ST018091
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/06/2024

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: Lay User/Patient
• Device Catalogue Number: FT18EN50NGF889N
• Device Lot Number: ST018091
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2023
• Initial Report FDA Received Date: 03/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2023
• 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: ANTIBIOTICS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown