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

Model Number	670190
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No device was returned for evaluation.The reporter provided product photographs; examination of these could not confirm the reported issue.During production this device type is 100% functionally tested for cuff inflation and symmetry prior to release.
Event or Problem Description
It was reported the device cuff did not inflate symmetrically.The reporter stated t16 ml of fluid had to be added until an adequate tracheal seal was obtained.No adverse effects reported.

• Brand Name: BIVONA FLEXTEND PEDIATRIC TRACHEOSTOMY TUBE
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• MDR Report Key: 11171407
• Report Number: 3012307300-2021-00427
• Device Sequence Number: 11491826
• Product Code: JOH
• UDI-Device Identifier: 15021312006094
• UDI-Public: 15021312006094
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K944178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/14/2021

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: 670190
• Device Catalogue Number: 670190
• Device Lot Number: 3939518
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2020
• Initial Report FDA Received Date: 01/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1