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

Model Number	670175
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the tube was found leaking on the connector following the ventilator alarming.
Event or Problem Description
Additional information received indicated that the problem was resolved by changing the tracheostomy tube.
Additional Manufacturer Narrative
Device evaluation a sample was received along with two images to perform an investigation.A visual inspection of the returned tracheostomy tube found it to be in used condition.Functional testing was performed using a leak test.The unit was inflated, and it was visually inspected.The tube inflated and no leakage was observed.The unit was submerged under water and followed by massaging the tube, squeezing the balloon, and moving the airway line back and forth.Still no leakage was detected.Root cause could be determinate since the complaint was not confirmed.A device history record (dhr) review was performed, and no issues were noted during manufacture.
Additional Manufacturer Narrative
Corrected data: type of reportable event corrected (updated b1).

• Brand Name: BIVONA
• Common Device Name: TRACHEOSTOMY TUBE AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 12606430
• Report Number: 3012307300-2021-09879
• Device Sequence Number: 11790238
• Product Code: JOH
• UDI-Device Identifier: 15021312006063
• UDI-Public: 15021312006063
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K083641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/22/2022

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 Model Number: 670175
• Device Lot Number: 3998004
• Was Device Available for Evaluation?: No
• 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: 09/11/2021
• Supplement Date Received by Manufacturer: 09/23/2021; 06/24/2022
• Initial Report FDA Received Date: 10/11/2021
• Supplement Report FDA Received Date: 06/30/2022; 07/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian