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

Catalog Number	67PFSS55
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/06/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that that after inserting a portex® bivona® neonatal and pediatric silicone tracheostomy tube, the cuff cracked on the tip of the tube.No injury was reported.

• Brand Name: PORTEX® BIVONA® NEONATAL AND PEDIATRIC SILICONE 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: 7419536
• Report Number: 3012307300-2018-01039
• Device Sequence Number: 19202984
• Product Code: JOH
• UDI-Device Identifier: 10351688518729
• UDI-Public: 10351688518729
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Report Date (Section B): 04/10/2018

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: 06/28/2020
• Device Catalogue Number: 67PFSS55
• Device Lot Number: 2983132
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2018
• Initial Report FDA Received Date: 04/10/2018
• Patient Sequence Number: 1