MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SMITHS MEDICAL SILICONE BIVONA TUBES NEO/PED; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	67PFPS45
Medical Device Problem Codes	Crack (1135); Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received that while a smiths medical tracheostomy was in use, device cracked at the hub.No adverse effects reported.

• Brand Name: SMITHS MEDICAL SILICONE BIVONA TUBES NEO/PED
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane n; minneapolis MN 55442
• MDR Report Key: 9235375
• Report Number: 3012307300-2019-05896
• Device Sequence Number: 16242735
• Product Code: JOH
• UDI-Device Identifier: 10351688518552
• UDI-Public: 10351688518552
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/24/2019

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: 07/18/2022
• Device Catalogue Number: 67PFPS45
• Device Lot Number: 3472138
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2019
• Initial Report FDA Received Date: 10/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1