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

Catalog Number	FT16HN55NGF088N
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/16/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer has not returned the device to the manufacturer for device evaluation.If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.
Event or Problem Description
It was reported that a portex® bivona® custom tracheostomy tube "neck circle piece" broke on the right side at the tracheostomy tube ties.The tube broke when the nurse attempted to insert the tracheostomy tube in the stoma.The tube was replaced to address the issue.No patient injury was reported.See mfr: 3012307300-2017-00603.
Additional Manufacturer Narrative
The customer reported that two devices contributed to two reported events (one device per event).The customer returned one device for evaluation.It could not be determined which associated occurrence the device was associated with; therefore, the evaluation of the device will be used for both related medwatches.The following mfr were submitted related to the evaluation: 3012307300-2017-00602 and 3012307300-2017-00603.One bivona® customized tracheostomy tube was returned for investigation.Visual inspection of the returned device found that one neckflange eyelet was torn completely and the other had abrasions on the inside of the eyelet.Investigation was unable to determine the root cause of the observed neckflange eyelet damage; however, investigation did not reveal an intrinsic manufacturing issue.

• 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: 6371903
• Report Number: 3012307300-2017-00602
• Device Sequence Number: 18967144
• Product Code: JOH
• UDI-Device Identifier: 15019517068764
• UDI-Public: 15019517068764
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2017

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: Nurse
• Device Expiration Date: 01/09/2022
• Device Catalogue Number: FT16HN55NGF088N
• Device Lot Number: DS001502
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/06/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/02/2017
• Supplement Report FDA Received Date: 04/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1