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

Catalog Number	FT18GN50NGF034N
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation in progress.
Event or Problem Description
It was reported that the cuff would not hold water.The patient was not able to hold volumes on ventilator so the trach was removed.It was placed in a baggie and the cuff was filled with saline.The baggie became wet over a short period of time.No further complications were reported.
Additional Manufacturer Narrative
One flextend tracheostomy tube was returned for analysis.Upon visual examination there were no non-conformances found.A leak test was performed resulting in no leaks.The cuff was filled with 10cc of water; no leak was found.Per the instructions for use (ifu), saline has the potential to crystalize which can cause the inflation valve to malfunction or cause blockage.Based on the evidence, the complaint was not confirmed leading to no root cause.

• Brand Name: BIVONA CUSTOM 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: 7774484
• Report Number: 3012307300-2018-03077
• Device Sequence Number: 1272113
• Product Code: JOH
• UDI-Device Identifier: 15019517157666
• UDI-Public: 15019517157666
• 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,Followup
• Report Date (Section B): 10/10/2018

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 Expiration Date: 07/10/2023
• Device Catalogue Number: FT18GN50NGF034N
• Device Lot Number: DS018265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2018
• Supplement Date Received by Manufacturer: 09/12/2018
• Initial Report FDA Received Date: 08/10/2018
• Supplement Report FDA Received Date: 10/10/2018
• 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