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

Catalog Number	67P040
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Oxygen Saturation (2477); Decreased Respiratory Rate (2485)
Date of Event	03/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3.Reason device not evaluated by mfg: other; device was not returned to manufacturer.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 a serious complication occurred with the bivona tracheostomy tube when the patient performed decannulation, and the patient almost lost her life.Even though it appeared that the balloon was inflated, it deflated and the patient decannulated.The cannula dislocated, and it was only noticed at the moment that the patient began to present respiratory discomfort, deflating quickly, developing to desaturation.When it was noticed that the cannula had come out, the mother replaced the cannula quickly.With the aid of the ambulance and oxygen they went to the hospital.Patient was on cardiorespiratory arrest about 5 minutes, and 7 minutes into the hospital doing resuscitation maneuvers, also had peri tracheostomy bleeding.When decannulation was observed in the trachea, the health professionals immediately changed the cannula.Right after the patient presented gasping; however, she improved after suction of a great amount of secretion during physiotherapy care.The patient was admitted in the hospital, already on a bilevel positive airway pressure (bipap) machine with good saturation, adequate perfusion, and agitated.This was the second time she has had this same problem with this bivona model.The date of the first event was 19-mar-2024.The patient had good development at this hospital, infectious triage exams without alteration, with a good expandability of the chest on x-ray, and was in condition to return to home care.It was also informed that the patient has mosaic chromosome 9 trisomy, atropine allergy, and paradoxical effect with ketamine.And the conduct was home discharge with high complexity cases, 7 days of antibiotic therapy, clavelin enteral, due manipulation of the decannulation, and basal standard kit.This report captures the first of two chronological events listed by the initial reporter.
Additional Manufacturer Narrative
Investigation summary: no product sample was received.One (1) photo was attached and reviewed.Complaint for the failure mode " a0251 - reported injury/adverse event (no device failure)" could not be confirmed by investigation as no samples were provided and no defect could be confirmed in the photo provided by the customer.If the product is returned, the manufacturer will reopen this complaint for further investigation.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.

• Brand Name: BIVONA TIGHT TO SHAFT PEDIATRIC V-NECK FLANGE 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 ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20641301
• Report Number: 9617604-2024-00856
• Device Sequence Number: 8169332
• Product Code: JOH
• UDI-Device Identifier: 15021312006278
• UDI-Public: (01)15021312006278(17)271024(10)4334887
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 67P040
• Device Lot Number: 4334887
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2024
• Supplement Date Received by Manufacturer: 11/27/2024
• Initial Report FDA Received Date: 11/08/2024
• Supplement Report FDA Received Date: 12/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/03/2022
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Life Threatening
• Patient Age: 22 MO
• Patient Sex: Female
• Patient Weight: 11 KG