MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA

Model Number	ZT19GN45ZGZ225N
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation results: one custom bivona tracheostomy tube was returned for investigation in used condition.Visual inspection of the device did not reveal any defects.Using a syringe, air was removed from the proximal cuff and the plug was sealed.The air remained evacuated from the cuff indicating there was no leak in the proximal cuff or red plug line.Air was allowed to reenter the proximal cuff so it returned to its natural resting state and the red plug was reseated.Using a syringe, 5 cc of air was inserted in the inflation valve.The distal cuff inflated.The device was then leak tested.No leaks were observed while applying pressure to the cuff and the balloon, tugging the airway lines or bending / twisting the shaft.The cuff was inserted with 5 cc of water and allowed to rest for three hours.There was no evidence of water leaking from the device and almost 4.5 cc of water was able to be evacuated from the cuff.The red plug was unseated and 5 cc of air was inserted into the inflation valve.The cuff fully inflated, but deflated quickly.The proximal cuff was cut to expose the shaft under the foam.The device was then leak tested again.A tiny leak was detected in the imbedded lumen in the shaft under the foam.It is likely that when the operator notched the shaft for the teflon tubing, a small nick occurred or insufficient adhesive was applied surrounding the teflon tubing.Based on where the location of the leak (i.E., under the foam cuff), the manufacturing leak test was unable to detect the leak.There have been 12 lots manufactured for part number zt19gn45zgz225n from august 2019 to august 2020, and this is the first complaint for this part number.Based on a five-year review of complaints this is the second compliant that identified a leak in the lumen under a foam cuff.No adverse trends have been identified related to this issue.The complaint investigation was shared with the custom lab build operators and quality inspectors.No corrective actions are planned at this time.
Event or Problem Description
It was reported that the cuff component of the custom bivona tracheostomy tube was defective.The exact nature of the defect was not stated.No patient injury or complications were reported in relation to this event.

• Brand Name: BIVONA
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• MDR Report Key: 10363356
• Report Number: 3012307300-2020-07787
• Device Sequence Number: 3043988
• Product Code: JOH
• UDI-Device Identifier: 15019517200409
• UDI-Public: 15019517200409
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/04/2020

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: Lay User/Patient
• Device Model Number: ZT19GN45ZGZ225N
• Device Catalogue Number: ZT19GN45ZGZ225N
• 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: 07/06/2020
• Initial Report FDA Received Date: 08/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 20 YR