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

Catalog Number	67SP040
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/19/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 a portex® bivona® neonatal and pediatric tts¿ (tight-to-shaft) tracheostomy tube inflation line began to come loose from where it was attached above the flange and that the glue had loosened.It was noted that the patient was known to pull at the tubing for inflation sometimes.The tracheostomy tube was proactively switched to another.No patient injury was reported.See mfr: 3012307300-2017-00188.
Additional Manufacturer Narrative
One bivona® 4.0mm tts¿ pediatric tracheostomy tube was returned for investigation.Visual inspection of the returned device was performed with the unaided eye and under normal plant lighting.During examination, it was observed that there was a faded "7" mark written on the silicone surface surrounding the base of the connector.Additionally, it was noted that there appeared to be a crack in the silicone surface surrounding the connector above the inflation line junction to the neck flange.The observed damaged area was microscopically inspected and it was found that the silicone had appeared to be torn away from the device above where the inflation line attached to the neck flange.Further inspection revealed that the bond between the airway line and the neck flange was good and the adhesive joint had remained intact.During functional testing, a standard syringe was used to insert 5cc's of air into the device inflation line; the cuff fully inflated.The device was then submerged in water and no bubbles (indicating a leak) were observed escaping from the device.Investigation determined that the root cause of the damage damage was the device being used in a manner inconsistent with the device instructions for use.

• Brand Name: PORTEX® BIVONA® NEONATAL AND PEDIATRIC TTS¿ (TIGHT-TO-SHAFT) TRACHEOSTOMY TUBES
• 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: 6254522
• Report Number: 3012307300-2017-00187
• Device Sequence Number: 721027
• Product Code: JOH
• UDI-Device Identifier: 15021312000726
• UDI-Public: 15021312000726
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K914088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2016

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 Expiration Date: 06/08/2021
• Device Catalogue Number: 67SP040
• Device Lot Number: 3216496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/19/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/16/2017
• Supplement Report FDA Received Date: 02/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 10 MO