MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. BIVONA FLEXTEND NEONATAL TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	60NFPS35
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.Date of event: unknown.No information has been provided to date.E1.Initial reporter last name unknown.E3.Initial reporter occupation unknown.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 there was a breakage at the lower edge and the spiral was exposed.The incident occurred at the patient`s house.There is unknown patient involvement and no harm reported.
Additional Manufacturer Narrative
H6.Evaluation codes: updated.No product or photos were returned therefore no device analysis could be completed.A device history record (dhr) review showed there were no discrepancies or non-conformances during the manufacturing of the reported lot number.If the product is returned the manufacturer will re-open the complaint for further device analysis.
Additional Manufacturer Narrative
H6: updated.H3: one sample was returned.During the visual inspection it was identified that the tip of the tracheostomy tube was damaged, an area with missing material or a break was identified that exposed the wire.The failure mode was confirmed.After performing the evaluation and reviewing the different ways to reproduce and detect the reported condition, it was identified that during the set-up process adjustments are made to the injection molding machine, where the reference parameters for the material filling control are generally adjusted.Therefore, the most probable root cause is that during the set-up process a part was generated with a short shot in the distal tip (reported condition) at the time of adjusting the filling control parameters, the part was not correctly identified and segregated since there was no scrap flow established at that moment.In addition, it was found that there is a very wide range in the reference parameters of the material fill control.A retrospective review of 12-month period was made for complaints originated related to this issue and no additional complaints were identified to this part number and lot.

• Brand Name: BIVONA FLEXTEND NEONATAL TRACHEOSTOMY TUBE
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19756458
• Report Number: 9617604-2024-00581
• Device Sequence Number: 9145404
• Product Code: JOH
• UDI-Device Identifier: 15021312516692
• UDI-Public: (01)15021312516692(17)280728(10)4411332
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K083641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/14/2025

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: Lay User/Patient
• Device Catalogue Number: 60NFPS35
• Device Lot Number: 4411332
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2024
• Supplement Date Received by Manufacturer: 07/22/2024; 04/15/2025
• Initial Report FDA Received Date: 07/16/2024
• Supplement Report FDA Received Date: 08/08/2024; 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown