MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. BIVONA SILICONE PEDIATRIC 5.0 TIGHT TO SHAFT FLEXTEND V NECK; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	67PFS50
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Aspiration/Inhalation (1725); Cough (4457)
Date of Event	02/22/2024
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 additional reportable information becomes available.
Event or Problem Description
It was reported that the "cannula blocking" was only possible on one side.There was patient involvement without any injury.The event arose immediately when the mother changed the cannula.According to the mother, the incorrect bilateral blockage resulted in a strong cough and possibly slight micro-aspiration.
Additional Manufacturer Narrative
H3 and h6.Investigation codes: updated.Investigation summary: the sample returned consisted of one (1) for p/n: 67pfs50 and l/n: 3962589, returned sample was received used and in a plastic bag.During visual inspection no damage or other defects were detected on the sample.The sample was inflated with the use of a syringe to detect any problem in the inflation system, the sample inflated with no problems.It was observed that cuff inflated as expected and symmetry value was 45%, greater than 33% as is specified in qp bivona tt- fg-tj.The failure modes of ¿occluded/blockage¿ was not confirmed.A capa was initiated to address the root cause of the investigation for cuffed products not inflating symmetrically, not maintaining inflation, and leakage.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.E1 - reporter phone:(b)(6).

• Brand Name: BIVONA SILICONE PEDIATRIC 5.0 TIGHT TO SHAFT FLEXTEND V NECK
• 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: 18980764
• Report Number: 9617604-2024-00255
• Device Sequence Number: 6299501
• Product Code: JOH
• UDI-Device Identifier: 10351688518644
• UDI-Public: (01)10351688518644(17)250420(10)3962589
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2024

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: Other
• Device Expiration Date: 04/20/2025
• Device Catalogue Number: 67PFS50
• Device Lot Number: 3962589
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/11/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/29/2024
• Supplement Date Received by Manufacturer: 04/03/2024
• Initial Report FDA Received Date: 03/26/2024
• Supplement Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2020
• 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