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

Model Number	FT21IN60NGF057N
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a total of 2 individual tracheal cannula experience a nightly loss of aqua volume (3ml in, 1.5ml out).Suspicion of leakage at the pilot.
Additional Manufacturer Narrative
Other, other text: h6: event problem and evaluation codes: updated.H10: device evaluation: visual inspection of the two returned devices did not identify any defects.The devices were leak tested per work instruction, (b)(4).No leaks were detected.The cuffs were inflated with 10 cc of water and the various portions of the inflation system were manipulated.No leaks were detected.The devices with 10 cc of water in the cuffs were allowed to rest several days.No leaks were evident while the device was resting.Using a syringe, the water was evacuated.Approximately 10 cc of water was removed, the minor difference is accounted for the small amount of water that remains in the inflation system.Based on the limited information in the complaint description, it is unknown what the caregiver used to inflate the cuffs, but using air would account for the nightly loss in volume.The reported problem could not be confirmed.No corrective actions are planned at this time.There were no non-conforming reports (ncrs) initiated for the lots or anomalies identified in the dhrs.

• Brand Name: BIVONA TUBES CUSTOM
• Common Device Name: TRACHEOSTOMY TUBE 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: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 13636085
• Report Number: 3012307300-2022-04229
• Device Sequence Number: 16685259
• Product Code: JOH
• UDI-Device Identifier: 15019517280845
• UDI-Public: 15019517280845
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2022

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: FT21IN60NGF057N
• Device Catalogue Number: FT21IN60NGF057N
• 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: 02/01/2022
• Supplement Date Received by Manufacturer: 03/21/2022
• Initial Report FDA Received Date: 03/01/2022
• Supplement Report FDA Received Date: 03/28/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown