MAUDE Adverse Event Report: SMITHS MEDICAL NORTH AMERICA PORTEX® BIVONA® CUSTOM ADULT TRACHEOSTOMY TUBES; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	FT15LN90NSC861N
Medical Device Problem Codes	Defective Device (2588); Infusion or Flow Problem (2964)
Health Effect - Clinical Codes	Respiratory Distress (2045); Extubate (2402); Patient Problem/Medical Problem (2688)
Date of Event	02/17/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).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 adult tracheostomy tube was defective and possibly caused airflow restriction during use with a patient.The device was inserted in the patient when the patient was in respiratory distress.The cuff patency was tested by the patient's mother prior to use.The cuff was filled with air.An emergency tracheostomy tube change was conducted, which was reported to have resolved the issue.No permanent injury was reported.
Event or Problem Description
It was further reported that patient received an emergent tracheostomy tube change as the patient was not ventilating at the time of the event.Additionally, it was reported that the patient did desaturate; however, the exact level was unknown.
Additional Manufacturer Narrative
A review of the device history record was performed, and no discrepancies were noted.Upon receipt of the returned product specimen for device evaluation, it was visually examined.One used tracheostomy tube was received.Visual examination revealed no non-conformities.There were also no discrepancies with respect to dimensional and curvature inspection.Functional testing for leakage was performed and found no leak.The reported issue could not be replicated.Upon consultation with the smiths medical respiratory therapist in-residence, further analysis of the reported information and the device again revealed no non-conformities.This clinical expert hypothesized that the reported issue is not uncommon in cases of tracheomalacia.It is possible that a unique physiological condition was present in this particular patient that may have led to respiratory distress and was unrelated to the device itself.While no definitive root cause could be determined, this investigation revealed no intrinsic evidence to suggest a root cause related to manufacturing.

• Brand Name: PORTEX® BIVONA® CUSTOM ADULT TRACHEOSTOMY TUBES
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL NORTH AMERICA; 201 west queen street; southington CT 06489
• MDR Report Key: 6427390
• Report Number: 3012307300-2017-00714
• Device Sequence Number: 13668281
• Product Code: JOH
• UDI-Device Identifier: 15019517035322
• UDI-Public: 15019517035322
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Patient Family Member or Friend
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: FT15LN90NSC861N
• Device Lot Number: SS005262
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2017
• Supplement Date Received by Manufacturer: Not provided; 08/01/2017
• Initial Report FDA Received Date: 03/23/2017
• Supplement Report FDA Received Date: 05/16/2017; 08/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 39 YR
• Patient Weight: 43