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

Model Number	67P025
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/27/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received that a smiths medical portex bivona tts cuffed pediatric with v neck flange tracheostomy tube cuff balloon would not inflate while in use with a nicu patient.Subsequently, a tracheostomy change out was required.There were no adverse patient effects.
Additional Manufacturer Narrative
Device evaluation: one tracheostomy was returned for evaluation.Visual inspection of the device found it to be in good physical condition.Device underwent functional testing; inflating the cuff with 5cc of air.Balloon and the whole cuff inflated completely without problem.Symmetry was 50 percent, which is within specification of 33.3 percent as the minimum required.The reported customer complaint was not confirmed.And while no definitive problem source to the reported issue could be determined, this investigation revealed no intrinsic evidence to suggest a cause of issue related to manufacturing.

• Brand Name: PORTEX BIVONA TTS CUFFED PEDIATRIC WITH V NECK FLANGE TRACHEOSTOMY
• 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: 8465784
• Report Number: 3012307300-2019-01682
• Device Sequence Number: 193104
• Product Code: JOH
• UDI-Device Identifier: 15021312006247
• UDI-Public: 15021312006247
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K944178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Expiration Date: 05/28/2020
• Device Model Number: 67P025
• Device Catalogue Number: 67P025
• Device Lot Number: 2971905
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2019
• Supplement Date Received by Manufacturer: 05/27/2019
• Initial Report FDA Received Date: 03/29/2019
• Supplement Report FDA Received Date: 06/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention