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

Catalog Number	FU15JN50NSF169N
Medical Device Problem Codes	Crack (1135); Torn Material (3024)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/13/2017
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 adult tracheostomy tube was cracked and torn.The issue was observed during use of the device.No patient injury was reported.
Additional Manufacturer Narrative
One customized uncuffed flextend¿ tracheostomy tube was returned for evaluation.Visual inspection of the device identified that the product identification on the neck flange was worn off.The shaft of the device was manipulated to reveal an approximately 8.25mm horizontal tear in the silicone material just above the neck flange and a 16mm tear on the distal side of the neck flange.No appearance of stretching was visible.Dimensional inspection of the device confirmed the correct shaft length as well as proximal and distal inner diameters.It was observed that the surface appearance of the damaged areas were irregular, suggestive of damage due to repeated use and propagating damage from device cleaning.A review of the device history record determined that the record was complete and the device met specifications.Based on the evidence, the complaint was confirmed.The evidence did not indicate that the issue was due to a manufacturing defect.

• Brand Name: PORTEX® BIVONA® CUSTOM 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: 6354658
• Report Number: 3012307300-2017-00562
• Device Sequence Number: 13847386
• Product Code: JOH
• UDI-Device Identifier: 15019517026641
• UDI-Public: 15019517026641
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2017

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: Health Professional
• Device Expiration Date: 09/26/2021
• Device Catalogue Number: FU15JN50NSF169N
• Device Lot Number: GS031034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/14/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/23/2017
• Supplement Report FDA Received Date: 06/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1