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

Model Number	67PFSS40
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2023
Type of Reportable Event	Malfunction
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 required.
Event or Problem Description
It was reported, that a trach change was done.No patient harm reported.
Additional Manufacturer Narrative
Two (2) photos were provided by the customer which were used to conduct the device analysis since the physical unit, by the time this investigation was being documented, had not been received.Photo one shows a packaging label for a tracheostomy tube of part number 67pfss40 and lot number 4344986; the device is not visible in the photo.Photo two shows a tracheostomy tube where the right-side flange is observed to be broken at the base of the tube; no other damage or dysfunctional conditions are observed.The complaint was confirmed.The root cause for the condition was unable to be determined based on the received photos.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.This issue will be monitored, and further actions taken accordingly.

• 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: 17131257
• Report Number: 3012307300-2023-06255
• Device Sequence Number: 12362263
• Product Code: JOH
• UDI-Device Identifier: 10351688518699
• UDI-Public: 10351688518699
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2023

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: Health Professional
• Device Model Number: 67PFSS40
• Device Catalogue Number: 67PFSS40
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2023
• Supplement Date Received by Manufacturer: 09/30/2023
• Initial Report FDA Received Date: 06/14/2023
• Supplement Report FDA Received Date: 10/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2022
• 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 Age: 2 YR
• Patient Sex: Female
• Patient Weight: 11 KG