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

Model Number	67PFPS50
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Unintended Deflation (4061)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a respiratory therapist (rt) was completing a patient assessment of tracheostomy tube balloon volume.Upon assessment the cuff was noted to be deflated, and rt found that valve on pilot balloon was missing.Patient (pediatric) was chewing on pilot balloon at time of assessment.The rt was unsure if the patient chewed valve out of balloon or if it fell out as rt was unable to locate the valve.Tracheostomy replaced.
Additional Manufacturer Narrative
Manufacture date are unknown, no information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when required.
Additional Manufacturer Narrative
Device evaluation: one device was returned for investigation.The pilot valve was not found during the visual inspection; complaint was confirmed.No lot number was provided, therefor no device history report (dhr) review could be completed.This problem is caused by the handling of the product, therefore the root cause could be due to the improper use of the product.No corrective actions are required since the root cause could be due to improper use of the product.

• 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: 17128650
• Report Number: 3012307300-2023-06239
• Device Sequence Number: 15312080
• Product Code: JOH
• UDI-Device Identifier: 10351688518569
• UDI-Public: 10351688518569
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2023

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: Health Professional
• Device Model Number: 67PFPS50
• Device Catalogue Number: 67PFPS50
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2023
• Supplement Date Received by Manufacturer: 07/07/2023
• Initial Report FDA Received Date: 06/14/2023
• Supplement Report FDA Received Date: 07/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown