MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA TIGHT TO SHAFT TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	670190
Medical Device Problem Codes	Leak/Splash (1354); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2024
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 cuff leaks.Significant asymmetry also observed after a pre-test of balloon with air.There was patient involvement and there was no injury, but there was needed of medical intervention.
Additional Manufacturer Narrative
Investigation summary: the sample returned consisted of one (1) for p/n: 670190-sa and l/n: 4286836, returned sample was received used, in a plastic bag.During visual inspection it was detected that the cuff did not inflate symmetrically, one side was bigger than the other side.Symmetry measurement was performed to confirm if the value was less than 33% established in the bivona tt-fg-tj qp.The symmetry value was 44% (16/36*100).The failure mode of ¿a0122 - cuff asymmetry¿ was not confirmed.The sample was inflated with the use of a syringe and submerged under water to detect any problem in the inflation system.The sample worked as expected.Capa-000862 was opened on january 5th, 2022, to address root cause investigation cuffed products do not inflate symmetrically and leaks.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 TRACHEOSTOMY TUBE
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19185362
• Report Number: 3012307300-2024-03042
• Device Sequence Number: 12613309
• Product Code: JOH
• UDI-Device Identifier: 15021312006094
• UDI-Public: (01)15021312006094(17)270711(10)4308123
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K083641
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2024

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: Health Professional
• Device Catalogue Number: 670190
• Device Lot Number: 4308123
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/23/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2024
• Supplement Date Received by Manufacturer: 05/28/2024
• Initial Report FDA Received Date: 04/25/2024
• Supplement Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2022
• 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 Age: 66 YR
• Patient Sex: Male