MAUDE Adverse Event Report: BIVONA; TRACHEOSTOMY TUBE AND TUBE CUFF

Model Number	65SP035
Medical Device Problem Codes	Inflation Problem (1310); Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One smiths medical tracheostomy|silicone - bivona tubes neo/ped aire-cuf and one picture was returned for analysis.The sample was tested on leak test.The test was performed under water leak testing and cuff symmetry visual aid, and it wasn't observed any leakage and it was seen well inflated.Then the unit was submerged under water, it wasn't observed any leakage.It was followed to massage the product, the balloon was squeezed, and the airway line was moved back and forth, no leakage was detected.The complaint is not confirmed.Based on the evidence, the complaint was not confirmed, and no fault was found.
Event or Problem Description
Information was received indicating that while in use of a smiths medical tracheostomy|silicone - bivona tubes neo/ped aire-cuf, the customer had to keep inflating the cuff every two hours.Otherwise, air pressure of the cuff lowered.No patient consequences were reported.No adverse effects were reported.

• Brand Name: BIVONA
• Common Device Name: TRACHEOSTOMY TUBE AND TUBE CUFF
• MDR Report Key: 12521327
• Report Number: 3012307300-2021-09567
• Device Sequence Number: 4428116
• Product Code: JOH
• UDI-Device Identifier: 15021312000290
• UDI-Public: 15021312000290
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K944178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/23/2021

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: 65SP035
• Device Catalogue Number: 65SP035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2021
• Initial Report FDA Received Date: 09/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown
• Patient Sequence Number: 1