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

Model Number	FT20IN40NSE031N
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hypoventilation (1916)
Date of Event	10/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was returned for evaluation.The device examination showed no defects.The device cuff was inflated using 5cc of air.The device was given leak testing and no leakage was detected.The device cuff was deflated, then filled with 5cc of fluid and left for 12 hours.When checked for leakage again there was no leakage detected.The cuff retained almost 5cc of fluid.The small loss of fluid was determined likely still in the cuff or inflation line.The investigation determined that the reported volume loss was not caused by leakage but by fluid that couldn't be withdrawn from the cuff/inflation line.
Event or Problem Description
It was reported the device cuff did not hold fluid; original volume of fluid was 4cc and cuff volume was later measured at 3.5cc.A patient tube change was required to continue patient therapy.No further adverse effects reported.

• 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: 10916073
• Report Number: 3012307300-2020-11902
• Device Sequence Number: 1429963
• Product Code: JOH
• UDI-Device Identifier: 15019517241440
• UDI-Public: 15019517241440
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• 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): 11/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Model Number: FT20IN40NSE031N
• Device Catalogue Number: FT20IN40NSE031N
• Device Lot Number: BS010369
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2020
• Initial Report FDA Received Date: 11/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention