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

Catalog Number	FT16BN40NSF107S
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is currently being evaluated; smiths medical will file a follow-up report detailing the results of the evaluation once it is completed.
Event or Problem Description
It was reported that the cuff of a portex® bivona® custom tracheotomy tube would not deflate.The patient's mother called the distributor to report that the tracheostomy tube could not be changed due to the cuff not deflating.The patient went to the emergency room for the doctors to the remove the tracheostomy tube, but the doctors were also successful after multiple attempts.The patient went to see an otolaryngologist, who was able to remove the tracheotomy tube.The pilot balloon and cuff were tested prior to insertion.No injury was reported.
Additional Manufacturer Narrative
A portex® bivona® custom tracheostomy tube was returned for analysis.The product was returned with the airway line cut in half and the inflation balloon detached from the device.The balloon was inflated, but the air would not release from the cuff once the syringe was removed.The device was dissected to locate the cause for being unable to deflate the cuff.The teflon tubing was located and matched the sized used in the device history record and measured within specification.There was no excessive adhesive or stray teflon coating present.A review of the manufacturing process and the quality assurance inspection was conducted and was considered adequate and correct.Based on the evidence, the problem was replicated.The root cause was not identified.

• Brand Name: PORTEX® BIVONA® CUSTOM TRACHEOTOMY 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: 6751808
• Report Number: 3012307300-2017-01607
• Device Sequence Number: 1243560
• Product Code: JOH
• UDI-Device Identifier: 15019517042061
• UDI-Public: 15019517042061
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2018

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: No Information
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: FT16BN40NSF107S
• Device Lot Number: DS005175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2017
• Supplement Date Received by Manufacturer: 12/28/2017
• Initial Report FDA Received Date: 07/28/2017
• Supplement Report FDA Received Date: 01/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1