MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX BIVONA NEONATAL TTS (TIGHT-TO-SHAFT) TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	67N030
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Information was received that a smiths medical portex bivona neonatal tts (tight-to-shaft) tracheostomy tube had a "faulty balloon".No adverse effects were reported.
Additional Manufacturer Narrative
Device evaluation: one bivona tracheostomy sample was received in used condition without its original packaging for evaluation.The sample was visually inspected and no discrepancies were found.A leak test was performed and when inflating the unit with air, it was seen that the cuff inflated and held the air properly.Next, an air cuff symmetry test was performed and the cuff inflated properly after being inflated/deflated four times.Additionally, the percentage result was found to be over the minimum acceptable, but the unit was still found to be within specification.To further investigate the issue, documents were reviewed and deemed adequate.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.Air cuff symmetry tests were also audited during thirty two (32) units finding no discrepancies.A review of the manufacturing process was conducted and was considered adequate and correct.Based on the evidence and testing, the complaint was not confirmed.No fault was found with the returned device.

• Brand Name: PORTEX BIVONA NEONATAL TTS (TIGHT-TO-SHAFT) 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: 9292538
• Report Number: 3012307300-2019-05949
• Device Sequence Number: 2448110
• Product Code: JOH
• UDI-Device Identifier: 15021312006216
• UDI-Public: 15021312006216
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/31/2019

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: 10/24/2023
• Device Model Number: 67N030
• Device Catalogue Number: 67N030
• Device Lot Number: 3715020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2019
• Supplement Date Received by Manufacturer: 12/07/2019
• Initial Report FDA Received Date: 11/07/2019
• Supplement Report FDA Received Date: 12/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1