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

Catalog Number	670175
Medical Device Problem Code	Suction Failure (4039)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2024
Type of Reportable Event	Serious Injury
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It was reported that the water could not be withdrawn through the pilot balloon after 29 days of use, thus inflation line was forced to be cut to withdraw the water and remove the tube.This was solved by replacing with a new one.There was a patient involvement, and no medical intervention was required, and the issue has been resolved.
Additional Manufacturer Narrative
The following field was updated with corrections: d4.Primary udi number: (b)(4).H1.Type of reportable event: serious injury h6.Investigation codes: updated investigation summary: the sample returned consisted of one (1) for p/n: 670175 in used condition, in a plastic bag.During visual inspection it was detected that the inflation line was cut.The customer reported that after 29 days of product use the water could not be extracted from the inflation system, the customer cut the inflation line to release the water from the product.During the days prior to the incident, no problems with product function were reported.Since the sample was cut by the customer, the failure mode was not confirmed.Based on the analysis performed on the sample provided and the reported by the customer, no root cause could be determined since the complaint was not confirmed.A device history record could not be completed as no lot number was received.

• Brand Name: BIVONA TRACHEOSTOMY TUBE, ADULT
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19354981
• Report Number: 3012307300-2024-03963
• Device Sequence Number: 7678053
• Product Code: JOH
• UDI-Device Identifier: 15021312006063
• UDI-Public: (01)15021312006063
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K944178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2024

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: Other
• Device Catalogue Number: 670175
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/16/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2024
• Supplement Date Received by Manufacturer: 06/07/2024
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 07/01/2024
• 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 Sex: Unknown