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

Model Number	ZT20GN80NSZ013N
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation: the device was returned for evaluation.The device was examined, and this showed slow leakage at the tube connector area.The examination showed the end of the tube shaft had a notch to allow for insertion of the airway line, however, the notch was too deep, which allowed for the notch puncturing the tube shaft.
Event or Problem Description
It was reported the device was in use with patient for 5 days when cuff leakage occurred.No adverse effects reported.
Additional Manufacturer Narrative
Other, other text: additional information was received that the intervention correction was necessary and that it was necessary to change the cannula.The patient showed signs of stress and it was found that there was a leak at the cuff site.This information changes the type of reportable of event to a serious injury.

• Brand Name: BIVONA CUSTOMIZED TRACHEOSTOMY TUBE
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 10898212
• Report Number: 3012307300-2020-11727
• Device Sequence Number: 11430794
• Product Code: JOH
• UDI-Device Identifier: 15019517234879
• UDI-Public: 15019517234879
• 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: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2021

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: No Information
• Device Model Number: ZT20GN80NSZ013N
• Device Catalogue Number: ZT20GN80NSZ013N
• Device Lot Number: BS008570
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/16/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/26/2020
• Supplement Date Received by Manufacturer: 04/16/2021
• Initial Report FDA Received Date: 11/24/2020
• Supplement Report FDA Received Date: 05/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1