MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONIA; TRACHEOSTOMY

Model Number 7.0 MM

Device Problems Fluid/Blood Leak (1250); Material Fragmentation (1261); Inflation Problem (1310); Leak/Splash (1354); Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/09/2020

Event Type  malfunction  

Event Description

Information received a smiths medical tracheostomy|silicone - bivona tubes custom cuff of a custom trach is inflating asymmetrically and is using twice the amount of water to create a seal.The pilot balloon is also leaking.No patient adverse events reported.

Manufacturer Narrative

Additional information was received indicating that when the syringe was removed after inflation, the entire plastic syringe port was noted to come out of the pilot balloon leading to inoperability of the cuff and saline leaking out.The respiratory therapist was then able to push the plastic port back into the pilot balloon to reinsert into the patient.There was then some observed saline leakage upon cuff inflation.There were no reported adverse patient effects.

Manufacturer Narrative

Device evaluation results: the two pictures provided are of an inflation valve that appears to be correctly seated into the inflation balloon.The outer edge of the inflation valve appears to be deformed on one side.Visual inspection of the returned device confirmed that the inflation valve was seated correctly and that that the portion of the valve that extends outside the balloon was deformed.The cuff on the device was unable to be inflated using the inflation valve in its current state since the tips of various sized syringes were unable to be inserted to actuate the valve.In order to inflate the cuff so the symmetry and inflation system could be checked, the deformed inflation valve was removed and another one was inserted into the balloon.The device inflated without issue.The device was leak tested and the cuff symmetry was measured.No leaks were detected for the entire device (i.E., balloon, airway line, neck flange, cuff, or lumen).Using a verified ruler (blue dot) the cuff symmetry passed the manufacturing specification of 1/3:2/3.No defects were identified with the device except for the deformity on the inflation valve.While the cuff was inflated, the non-deformed inflation valve was removed, and the original inflation valve was reinserted into the device.The inflation valve functioned and did not allow the fluid in the cuff or the balloon to leak.The investigation determined that it is unlikely that the deformity in the inflation valve was present when the device was released for distribution since all custom devices are 100% inspected for cuff symmetry and leaks prior to packaging and the inflation valve in its current state prevented the cuff from being inflated.Moreover, the complaint description details indicate that the device was able to be inflated.The investigation could not confirm whether the deformity in the inflation valve was caused by exposure to heat during reprocessing or force.Review of complaints did not reveal other reports of a deformed inflation valves.No corrective actions are planned at this time.Smiths medical regularly analyzes complaint data and trends and will take further actions accordingly.

• Brand Name: BIVONIA
• Type of Device: TRACHEOSTOMY
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• MDR Report Key: 10257901
• MDR Text Key: 199048114
• Report Number: 3012307300-2020-07147
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor
• Type of Report: Initial,Followup,Followup
• Report Date: 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 7.0 MM
• Device Catalogue Number: HT14FS70NSC353N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 33 YR