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

Catalog Number	670170
Medical Device Problem Codes	Microbial Contamination of Device (2303); Optical Discoloration (2999)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other text: 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 "mold" was forming in the cannula.The event occurred during a period of use of about one week when the "discoloration" could be seen, event occurred in the home environment, and the operator of the device was the patient/relatives.No patient injury or intervention was reported and the outcome of the event was resolved.
Additional Manufacturer Narrative
Other, other text: additional information is provided for d.10, h.2, h.3, and h.6.(b)(4) samples and one photo received for evaluation.Visual inspection revealed the samples were received in used conditions without the original packaging.Functional testing was performed, and the reported issue was unable to be replicated.The root cause was unable to be determined.Device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.For all enquiries or follow-up questions related to the record, do not use regulatory.Responses@smiths-medical.Com located in sections g.1., please direct those to the following: regulatory.Responses@icumed.Com.D.4 full udi number: (b)(4).

• Brand Name: BIVONA TIGHT TO SHAFT TRACHEOSTOMY TUBE
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 18231882
• Report Number: 3012307300-2023-10813
• Device Sequence Number: 15199527
• Product Code: JOH
• UDI-Device Identifier: 15021312006056
• UDI-Public: 15021312006056
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K083641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2024

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: Lay User/Patient
• Device Catalogue Number: 670170
• Device Lot Number: 4362628
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2023
• Supplement Date Received by Manufacturer: 11/06/2023
• Initial Report FDA Received Date: 11/29/2023
• Supplement Report FDA Received Date: 06/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown