MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA AIRE-CUF 6.0 MM TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	750160
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Foreign report source: (b)(6).
Event or Problem Description
Information was received that a smiths medical bivona aire-cuf 6.0 mm tracheostomy tube was placed with a patient on (b)(6) 2019 at the hospital.The reporter stated that they "need to refill the cuff more often than they used to.It is not only 1 ml, but 3-4 ml every 6 hour." it was also reported the user wanted to wait to replace the tube until the patient's planned change out date.They will continue to refill the cuff with air.There were no adverse patient effects.
Additional Manufacturer Narrative
A sample was received to perform an investigation.A visual inspection of the returned device was performed at 12 inches under normal lighting and no damage was observed on the cuff or airline.Functional testing was performed by inflating the cuff with 15cc of air.No leaks were detected.The unit was submerged under water to observe for any leakage and no leakage was detected.A review of the manufacturing process found that all inspections and verifications were being performed by the production personnel and verified by the quality inspectors.As a preventive measure, production personnel were made aware of the defect reported by the customer.It was determined that the most probable root cause was that damage occurred after the product left the manufacturing facility.A device history record (dhr) review could not be performed as the lot number was unknown.No root cause could be determined as the complaint was unable to be confirmed.Additional information d10, h2, h3 and h6.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# (b)(4).

• Brand Name: BIVONA AIRE-CUF 6.0 MM TRACHEOSTOMY TUBE
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 9532675
• Report Number: 3012307300-2019-07470
• Device Sequence Number: 2245448
• Product Code: JOH
• UDI-Device Identifier: 15021312006407
• UDI-Public: 15021312006407
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K914088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 750160
• Device Catalogue Number: 750160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2019
• Supplement Date Received by Manufacturer: 07/15/2022
• Initial Report FDA Received Date: 12/30/2019
• Supplement Report FDA Received Date: 09/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Patient Sex: Unknown