MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. BIVONA TUBES, MID-RANGE ADULT AIRE-CUF; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	750190
Medical Device Problem Codes	Contamination (1120); Device Dislodged or Dislocated (2923); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter phone: (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.
Event or Problem Description
It was reported that the pilot line spring valve was pushed into the valve, and it was difficult to access for inflation/deflation/cuff pressure checks.The trach was changed out for new one.There was a patient involvement, however there was no patient harm/adverse event reported.
Additional Manufacturer Narrative
One device was received for evaluation in used condition.As received the spring valve was observed to be lodged inside the pilot balloon.Inspection of the inside of the pilot balloon showed unknown residuals.Additionally, two tears were observed in the pilot balloon.The deformation on the tears were uneven.The complaint of 'pilot line spring valve pushed into the valve' was confirmed.The probable cause is due a twisting motion or excessive force was applied to the inflation valve when attaching the syringe, which advanced the valve down into the balloon.Device history review (dhr) found there were no non-conforming material reports (ncmrs) initiated for the lot or anomalies identified in the dhr.

• Brand Name: BIVONA TUBES, MID-RANGE ADULT AIRE-CUF
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; avenida calidad no.4; parque industrial int.; tijuana, b.c. c.p. 22425 ; MX 22425
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21873217
• Report Number: 3012307300-2025-04550
• Device Sequence Number: 7719115
• Product Code: JOH
• UDI-Device Identifier: 15021312006438
• UDI-Public: (01)15021312006438(17)270331(10)4255461
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K083641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 07/07/2025

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: Other
• Device Catalogue Number: 750190
• Device Lot Number: 4255461
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2025
• Supplement Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2022
• 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: Required Intervention
• Patient Sex: Unknown