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

Model Number	65SP045
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use, the patient pulled the inflation line and tore it.No patient injury.
Additional Manufacturer Narrative
Other, other text: one unit was returned for investigation.Upon physical inspection, condition reported in complaint is visible, however, this does not assure us that there is still a failure of the process, since mishandling by the user by not using the tracheostomy device correctly cause the rupture.It was found that the complained issue could not be duplicated.Based on investigation results is that damaged occurred after the product left smiths medical facilities.Dhr review was not completed as no lot number was provided.

• Brand Name: BIVONA TUBES NEO/PED AIRE-CUF
• Common Device Name: TRACHEOSTOMY TUBE AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 3-10-15, hakata station east,; minneapolis, MN 55442
• MDR Report Key: 12981432
• Report Number: 3012307300-2021-12638
• Device Sequence Number: 14660133
• Product Code: JOH
• UDI-Device Identifier: 15021312000313
• UDI-Public: 15021312000313
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K944178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: 65SP045
• Device Catalogue Number: 65SP045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2021
• Supplement Date Received by Manufacturer: 11/11/2021
• Initial Report FDA Received Date: 12/10/2021
• Supplement Report FDA Received Date: 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown