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

Model Number	60PFSS35
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient experienced a break in the trach flange.Customer is concerned as this is an ongoing issue.There has been no report of observable clinical symptoms or a change in symptoms identified in the patient.
Additional Manufacturer Narrative
Expiration date and manufacture date are unknown.No information is available based on reported lot number.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
H3.Device evaluated by manufacturer and h6.Health impact, and evaluation codes: updated.One device was received for investigation.The reported issue was confirmed during visual inspection, which verified that the device eyelet was broken.However, no product lot number was provided, therefore, no review of manufacturing device history records could be conducted.Based on the available information, the complaint was confirmed, but no root cause could be established.A notification with this complaint's details was presented to production personnel.

• 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; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 16468563
• Report Number: 3012307300-2023-01906
• Device Sequence Number: 7774516
• Product Code: JOH
• UDI-Device Identifier: 15021312516777
• UDI-Public: 15021312516777
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K944178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2023

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: 60PFSS35
• Device Catalogue Number: 60PFSS35
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/14/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2023
• Supplement Date Received by Manufacturer: 05/11/2023
• Initial Report FDA Received Date: 03/02/2023
• Supplement Report FDA Received Date: 05/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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