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

Catalog Number	CM1930N
Medical Device Problem Code	Hole In Material (1293)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/22/2017
Type of Reportable Event	Serious Injury
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 tracheostomy tube cuff had a small hole.The issue was spontaneously observed by the patient's parents during the night at the patient's home.The device had been in use for 2 weeks prior to the event.It was noted that the cuff patency was tested prior to use and the cuff was filled with 8ml of sterile water.The tracheostomy tube 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.During functional testing, the device cuff was inflated with 20 cc of air.The device cuff was unable to fully inflate and immediately deflated as air escaped from a small hole in the cuff.Visual inspection of the device cuff revealed tiny scratches next to the hole in the cuff.The cuff of the device was then removed from the tracheostomy tube shaft and the wall thickness of the cuff was measured.The cuff wall thickness was found to pass specification.Investigation was unable to definitely determine the root cause of the observed cuff hole.

• Brand Name: PORTEX® BIVONA® CUSTOM 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: 6508899
• Report Number: 3012307300-2017-00866
• Device Sequence Number: 1330811
• 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,Followup
• Report Date (Section B): 05/11/2018

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: 12/19/2021
• Device Catalogue Number: CM1930N
• Device Lot Number: DS000859
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2017
• Supplement Date Received by Manufacturer: Not provided; 05/12/2017
• Initial Report FDA Received Date: 04/20/2017
• Supplement Report FDA Received Date: 05/24/2017; 05/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1