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

Model Number	67SP050
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/25/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received that a smiths medical bivona tts cuffed pediatric with v neck flange tracheostomy tube cuff would not inflate.No adverse patient effects were reported.
Additional Manufacturer Narrative
One tracheostomy was returned for evaluation.Visual inspection of the device found it to be in good physical condition.Upon inflation of the cuff, it was noted the cuff was not inflating circumferentially.The balloon was manipulated, which resulted in the whole cuff inflating.It was then deflated and inflated a total of four times; all inflating completely.When measuring the cuff, all were within specification.While no definitive problem source to the reported issue could be determined, this investigation revealed no intrinsic evidence to suggest a root cause related to manufacturing.

• Brand Name: BIVONA TTS CUFFED PEDIATRIC 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: 8384138
• Report Number: 3012307300-2019-01000
• Device Sequence Number: 252886
• Product Code: JOH
• UDI-Device Identifier: 15021312000740
• UDI-Public: 15021312000740
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K914088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2019

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: 08/29/2022
• Device Model Number: 67SP050
• Device Catalogue Number: 67SP050
• Device Lot Number: 3494048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2019
• Supplement Date Received by Manufacturer: 03/31/2019
• Initial Report FDA Received Date: 03/01/2019
• Supplement Report FDA Received Date: 04/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 4 YR