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

Catalog Number	67PFSS55
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the customer noticed a spontaneous leak either in the cuff or in the blocker line after three months of use.The customer did not know the number of preparations nor the type of processing.There was patient involvement.The patient required repeated suction due to increased stimulus and leaking water, but besides that, no patient harm/adverse event was reported.The operator of the device was the patient, and the event took place in the patients¿ house and the products showed deficiencies immediately upon use.The customer said that device preparations were made according to the instructions.Two devices were involved representing the same patient.The second reported device was documented on (b)(4).
Additional Manufacturer Narrative
E1 initial reporter phone number: (b)(6).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.
Additional Manufacturer Narrative
H3 and h6.Evaluation codes: updated.One device sample was received in used condition, decontaminated and in a plastic bag.Per visual inspection, the cuff is slightly inflated.Per functional testing, the device was inflated with the use of a syringe to detect any problem in the inflation system, a leak was identified in the inflation line.The complaint was confirmed; however, it was detected by the customer after three (3) months of use in the patient.A root cause for the condition was not identified.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.This issue will be monitored, and further actions taken accordingly.The complaint fault has been escalated to address a full root cause investigation.

• Brand Name: BIVONA FLEXTEND PEDIATRIC AND NEONATAL TRACH 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: 18546141
• Report Number: 9617604-2024-00068
• Device Sequence Number: 7923529
• Product Code: JOH
• UDI-Device Identifier: 10351688518729
• UDI-Public: 10351688518729
• 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,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2024

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 67PFSS55
• Device Lot Number: 4395774
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/10/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2023
• Supplement Date Received by Manufacturer: 02/28/2024
• Initial Report FDA Received Date: 01/19/2024
• Supplement Report FDA Received Date: 03/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male