MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® BIVONA® TTS¿ TRACHEOSTOMY TUBES; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	CM1930N
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/22/2017
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® custom 8.0 mm tts¿ tracheostomy tube burst spontaneously during the night.The device was in use with the patient at home.The tracheostomy tube had been in use for two weeks.The patient's parents heard the alarm and noticed the fault.Cuff patency was tested prior to use, and the cuff was filled with 8ml of sterile water.The cannula was exchanged for a new one.No patient injury was reported.
Additional Manufacturer Narrative
One bivona® 8.0 mm custom tracheostomy tube was returned for investigation.A review of the device history record for the reported lot found no abnormalities.Functional testing could not be performed on the returned device as the device cuff was cut/torn away from the end of the device.Visual inspection of the cuff found that tiny scratches next to the ripped cuff.The cuff of the device was removed from the returned sample and the wall thickness of the cuff was measured.The cuff thickness was found to be within specification.Investigation was unable to definitively determine the root cause of the observed cut in the cuff.

• Brand Name: PORTEX® BIVONA® TTS¿ 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: 6508895
• Report Number: 3012307300-2017-00867
• Device Sequence Number: 16364947
• Product Code: JOH
• UDI-Device Identifier: 15019517033427
• UDI-Public: 15019517033427
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2017

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: Patient Family Member or Friend
• Device Expiration Date: 12/19/2016
• Device Catalogue Number: CM1930N
• Device Lot Number: DS000859
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/29/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/20/2017
• Supplement Report FDA Received Date: 05/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1