MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® BIVONA® AIRE-CUF® PEDIATRIC TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	65P050
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional 510(k) - k083641.Smiths medical has received the sample device.A full evaluation is anticipated, but not yet begun, as the device is currently in transit to the investigation site.
Event or Problem Description
It was reported that the flange of a portex® bivona® aire-cuf® pediatric tracheostomy tube was broken.The tracheostomy tube had been in use for two weeks when the fault occurred.No injury was reported.
Additional Manufacturer Narrative
One photo was returned for evaluation.Visual evaluation of the image found that the neck flange was broken.One device was returned for evaluation in used condition.Visual inspection of the device found that there was a split on the right side of the neck flange and the left side of the neck flange was broken.A review of the testing and inspection documents was performed and considered adequate and correct.A review of the manufacturing process on a similar part was performed and found no issues.A review of 32 devices was performed for molding issues and found no damage.Based on the evidence, a root cause was unable to be confirmed.It was concluded that the damage likely occurred outside of the manufacturing facility.

• Brand Name: PORTEX® BIVONA® AIRE-CUF® PEDIATRIC 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: 6674919
• Report Number: 3012307300-2017-01387
• Device Sequence Number: 1882897
• Product Code: JOH
• UDI-Device Identifier: 15021312005998
• UDI-Public: 15021312005998
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K944178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2017

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: Health Professional
• Device Catalogue Number: 65P050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2017
• Supplement Date Received by Manufacturer: 10/12/2017
• Initial Report FDA Received Date: 06/28/2017
• Supplement Report FDA Received Date: 10/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 5 YR