MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA ADULT TIGHT TO SHAFT WITH CUFF, 7.5MM; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	670175
Medical Device Problem Codes	Gas/Air Leak (2946); Unintended Deflation (4061)
Health Effect - Clinical Codes	Low Oxygen Saturation (2477); Decreased Respiratory Rate (2485)
Date of Event	03/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1 - additional phone number provided: (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 patient was discharged from intensive care and presented with respiratory deterioration, as congestion and desaturation.The patient had to be ventilated on a portable ventilator in the pneumology department.Despite prior re-inflation of the cuff with a volume of 6 ml, the leaks have persisted.Facility injected up to "18 ml ad" to eliminate the leaks.Significant asymmetry was also observed after a pre-test of the balloon with air when a 7.5mm cannula was changed to a 9mm cannula.After testing with another 9mm cannula, it was observed to have perfect symmetry of the balloon.There was patient involvement and there is adverse event/human harm.The place of occurrence was the hospital.There was no injury, but there was need of medical intervention.
Additional Manufacturer Narrative
H3 and h6.Evaluation codes: updated.One device sample was received in used condition, in a plastic bag.During visual inspection no visual defects were detected, the cuff inflates properly.The sample was inflated with the use of a syringe and submerged under water to detect any problem in the inflation system, the sample works as expected.The complaint could not be confirmed/replicated.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.No action was taken.

• Brand Name: BIVONA ADULT TIGHT TO SHAFT WITH CUFF, 7.5MM
• 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: 19176030
• Report Number: 3012307300-2024-02984
• Device Sequence Number: 6367784
• Product Code: JOH
• UDI-Device Identifier: 15021312006063
• UDI-Public: (01)15021312006063(17)280111(10)4366562
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2024

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: 670175
• Device Lot Number: 4366562
• 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: 05/07/2024
• Initial Report FDA Received Date: 04/24/2024
• Supplement Report FDA Received Date: 06/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2023
• 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 Age: 66 YR
• Patient Sex: Male