MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA TUBES ADULT AIRE-CUF; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	750180
Medical Device Problem Codes	Inflation Problem (1310); Inadequacy of Device Shape and/or Size (1583); Patient Device Interaction Problem (4001); Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient felt uncomfortable after the tracheostomy tube had been placed for 3 days.Unusual gradual cuff deflation was found upon removal of the tube.An asymmetric cuff was also observed when inflated.This problem was solved by replacing with a new one.This event occurred in the patient home and while in use of patient.There was a patient involvement and no patient harm/adverse event reported.It was reported that no further information is available.
Additional Manufacturer Narrative
E1 additional contact: (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
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 was not confirmed/duplicated.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 TUBES ADULT AIRE-CUF
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 w 23rd ave; gary IN 46406
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19183375
• Report Number: 1824231-2024-00043
• Device Sequence Number: 7431134
• Product Code: JOH
• UDI-Device Identifier: 15021312006421
• UDI-Public: (01)15021312006421(17)240328(10)3751208
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2024

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 Expiration Date: 03/28/2024
• Device Catalogue Number: 750180
• Device Lot Number: 3751208
• 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: 03/29/2024
• Supplement Date Received by Manufacturer: 05/07/2024
• Initial Report FDA Received Date: 04/25/2024
• Supplement Report FDA Received Date: 06/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2019
• 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