MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA CUSTOM 5.5 FIXED TIGHT TO SHAFT; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	HT23CS55NSA960N
Medical Device Problem Codes	Gas/Air Leak (2946); Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot number, full udi number, expiration date, and manufacture date are unknown; no information has been provided to date.Phone number extension: (b)(6).Device has been discarded by the customer.Device evaluation: no product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.No lot number was provided, therefore no device history report (dhr) review could be performed.If the product is returned, the manufacturer will reopen this complaint for further investigation.
Event or Problem Description
It was reported that the balloon on the trach keeps deflating and is not holding air.The distributer had to send a replacement trach emergently to provide proper working product to their customer.They need a trach that will stay in place.No patient harm/adverse event reported.In addition to the above documentation, the patient's mother stated that she always inflates before putting any product into her son to make sure there was no defect on the product.

• Brand Name: BIVONA CUSTOM 5.5 FIXED 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: 18951096
• Report Number: 1824231-2024-00028
• Device Sequence Number: 7348800
• Product Code: JOH
• UDI-Device Identifier: 15019517341683
• UDI-Public: (01)15019517341683
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 03/21/2024

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: Other
• Device Catalogue Number: HT23CS55NSA960N
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2024
• Initial Report FDA Received Date: 03/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 20 YR
• Patient Sex: Male