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

Model Number	HT14FS70NSC353N
Medical Device Problem Codes	Material Fragmentation (1261); Inflation Problem (1310); Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/10/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that the cuff to a smiths medical portex bivona custom tts standard hyperflex tracheostomy tube was reported to be inflating asymmetrically and using twice the amount of water to create a seal.The pilot balloon was also reported to be leaking.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.
Additional Manufacturer Narrative
Other, other text: h3: two pictures of an inflation valve were provided for evaluation.The inflation valve appeared to be correctly sealed into the inflation balloon.The outer edge of the inflation valve appeared to be deformed on one side.One bivona custom tracheostomy tube was returned for evaluation.Visual inspection of the returned device confirmed that the inflation valve was seated correctly and 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 (e.G., 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 200% 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.

• Brand Name: BIVONA CUSTOMIZED 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: 10271905
• Report Number: 3012307300-2020-07303
• Device Sequence Number: 16344668
• Product Code: JOH
• UDI-Device Identifier: 10351688766038
• UDI-Public: 10351688766038
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2020

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: HT14FS70NSC353N
• Device Catalogue Number: HT14FS70NSC353N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/19/2020
• Supplement Date Received by Manufacturer: 10/23/2020
• Initial Report FDA Received Date: 07/14/2020
• Supplement Report FDA Received Date: 11/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1