MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. BIVONA TUBES NEO/PED FLEXTEND PLUS; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	67PFP60
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: event date unknown.H3: device not received by manufacturer.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 are problems with the balloon: it does not swell evenly, which creates difficulties in ventilation.Troubleshooting was done but the problem persists and the cannulas cannot be used.When looking at the cannula compared to others there is a gap between the stem and the end of the balloon.There was patient involvement and unknown patient harm.
Additional Manufacturer Narrative
Two photos were provided for investigation.It is not possible to confirm the condition reported by the customer, it is not clear from the photos if the cuff inflates symmetrically.In addition, it is necessary to perform the asymmetry test on the physical sample to confirm the condition.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.

• Brand Name: BIVONA TUBES NEO/PED FLEXTEND PLUS
• 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: 21358102
• Report Number: 9617604-2025-00129
• Device Sequence Number: 8451612
• Product Code: JOH
• UDI-Device Identifier: 10351688518538
• UDI-Public: (01)10351688518538(17)280819(10)4424703
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2025

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: 67PFP60
• Device Lot Number: 4424703
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2025
• Supplement Date Received by Manufacturer: 02/21/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 03/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/29/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown