MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX BIVONA TTS CUFFED NEONATAL WITH V NECK FLANGE TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	67N030
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: one tracheostomy sample from the reported lot was received in used condition without the original packaging.Immediate visual inspection found no discrepancies or damage in the sample.An inflation test was completed and it was noted that when inflating the unit, it was seen that the pilot balloon was inflated, but all the air was stuck in it.According to the ifu, the balloon was manipulated, and the whole cuff inflated.After the whole cuff inflated, it was deflated and inflated four times, all the times the cuff inflated completely.When measuring the cuff, the percentage for the symmetry was found to be within specification.The balloon and airway assembly operation and assembly were reviewed with no discrepancies.Inflation tests were audited during thirty two (32) units finding no deflated cuffs and no symmetry issues.A review of the manufacturing process was conducted and was considered adequate and correct.A review of the dhr was additionally completed and found no discrepancies.Based on the evidence and testing, the complaint was not confirmed.No fault was found with the device.
Event or Problem Description
Information was received that a smiths medical portex bivona tts cuffed neonatal with v neck flange tracheostomy tube pilot balloon inflated, but the cuff did not.No adverse patient effects were reported.

• Brand Name: PORTEX BIVONA TTS CUFFED NEONATAL WITH V NECK FLANGE 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: 8620892
• Report Number: 3012307300-2019-02715
• Device Sequence Number: 19376450
• Product Code: JOH
• UDI-Device Identifier: 15021312006216
• UDI-Public: 15021312006216
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K944178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/17/2019

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: No Information
• Device Expiration Date: 06/16/2022
• Device Model Number: 67N030
• Device Catalogue Number: 67N030
• Device Lot Number: 3450372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2019
• Initial Report FDA Received Date: 05/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1