MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA TRACHEOSTOMY TUBE, NEONATAL PEDIATRIC; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number	67PFS40
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	Decreased Respiratory Rate (2485)
Date of Event	02/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other, 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 required.
Event or Problem Description
It was reported that the patient felt their tracheostomy was blocked.An emergency tracheostomy tube change was done and upon insertion, the patient noted they were uncomfortable with increased work of breathing.A second trach change was done which resolved the issue.On inspection, it was noted that the cuff had inflated asymmetrically.
Event or Problem Description
Additional information received via email.There was no patient harm.There was medical intervention, an emergency tracheostomy tube change required due to cuff not inflating correctly.The outcome of the event was resolved.

• Brand Name: BIVONA TRACHEOSTOMY TUBE, NEONATAL PEDIATRIC
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• 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: 17187151
• Report Number: 3012307300-2023-06564
• Device Sequence Number: 6248792
• Product Code: JOH
• UDI-Device Identifier: 10351688518620
• UDI-Public: 10351688518620
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K944178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/19/2024
• Device Model Number: 67PFS40
• Device Catalogue Number: 67PFS40
• Device Lot Number: 3735240
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2023
• Supplement Date Received by Manufacturer: 12/07/2023
• Initial Report FDA Received Date: 06/22/2023
• Supplement Report FDA Received Date: 01/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2019
• 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 Age: 2 YR
• Patient Sex: Male
• Patient Weight: 11 KG
• Patient Race: White