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

Model Number	FT21BN35NGF066N
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was unable to be evaluated as it was not returned.If the device is received in the future an evaluation will be performed.The reported event was unable to be confirmed or replicated.A cause of the reported event could not be determined at this time.Dhr review was not completed as there was no lot information provided.
Event or Problem Description
It was reported that the cuff was not inflating despite attempting multiple times to inflate.The pilot balloon will inflate but not the cuff.There was no patient injury reported.
Additional Manufacturer Narrative
The device was unable to be evaluated as it was not returned.If the device is received in the future an evaluation will be performed.The reported event was unable to be confirmed or replicated.A cause of the reported event could not be determined at this time.Dhr review was not completed as there was no lot information provided.
Event or Problem Description
It was reported that the cuff was not inflating despite attempting multiple times to inflate.The pilot balloon will inflate but not the cuff.There was no patient injury reported.
Additional Manufacturer Narrative
H6: event problem and evaluation codes: updated.H10: device evaluation: the device was returned for investigation.Visual inspection of the returned device under normal lighting did not identify a defect.Functional inspection of the cuff was performed using 5 cc of air.The cuff partially inflated.Following the instruction for use, the pilot balloon was squeezed and the cuff fully inflated.The device was deflated, allowed to rest, and re-inflated fully several times.The reported problem could not be confirmed.No fault was found with the device.The cause of the reported problem could not be determined.No corrective actions are planned at this time.A dhr review was unable to be performed since no lot number was provided.

• Brand Name: BIVONA
• 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: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 13515104
• Report Number: 3012307300-2022-03223
• Device Sequence Number: 4207175
• Product Code: JOH
• UDI-Device Identifier: 15019517258097
• UDI-Public: 15019517258097
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/14/2023

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: FT21BN35NGF066N
• Device Catalogue Number: FT21BN35NGF066N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2021
• Supplement Date Received by Manufacturer: 03/07/2022; 06/14/2023
• Initial Report FDA Received Date: 02/11/2022
• Supplement Report FDA Received Date: 03/29/2022; 06/14/2023
• 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