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

Catalog Number	60A160
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma: additional 510(k) number: k083641.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 the outer diameter of a portex® bivona® uncuffed adult tracheostomy tube was too wide to allow for attachment to the ventilator.The tracheostomy tube had been inserted into the stoma of the patient for a weekly tracheostomy tube change.After insertion, the respiratory therapist attempted to reconnect the ventilator to the tracheostomy tube, which is when it was discovered the outer diameter of the tracheostomy tube to connect to the ventilator.The respiratory therapist removed the tracheostomy tube and inserted another tube of the same size and attached it to the ventilator.No injury was reported.
Additional Manufacturer Narrative
The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.One used device was received for evaluation.Visual inspection found the end of the connector to be deformed.Using a taper gauge, the connector failed the required level of inspection for acceptance.While no definitive root cause to the reported issue could be determined, this investigation revealed no intrinsic evidence to suggest a root cause related to manufacturing.

• Brand Name: PORTEX® BIVONA® UNCUFFED ADULT 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: 6622485
• Report Number: 3012307300-2017-01213
• Device Sequence Number: 19033181
• Product Code: JOH
• UDI-Device Identifier: 15021312005554
• UDI-Public: 15021312005554
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K913859
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2017

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: Respiratory Therapist
• Device Expiration Date: 01/28/2021
• Device Catalogue Number: 60A160
• Device Lot Number: 3135312
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2017
• Supplement Date Received by Manufacturer: 10/16/2017
• Initial Report FDA Received Date: 06/08/2017
• Supplement Report FDA Received Date: 10/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 16 YR
• Patient Weight: 50