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

Model Number	670175
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The tube was returned and a chunk of material could be seen missing on the airway line.The device was leak tested and the leak could be found where the material was missing.It is unlikely, due to the size of the defect that the device passed the functional and visual inspections performed throughout the manufacturing and quality inspection processes.The instruction for use states under contraindicatons: do not use in conjunction with lasers or electrosurgical devices where their output may contact and damage the tube.The ifu states under warnings: the device must be thoroughly inspected for signs of damage or wear prior to each use.Guard against product damage by avoiding contact with sharp edges.During reprocessing aggressive scrubbing of the tub or use of a hard bristled brush or sharp wire-mounted swab may damage the surface of the tube.
Event or Problem Description
Information was received indicating that a smiths medical tracheostomy tube was leaking at the shaft.There were no reported adverse events.

• Brand Name: BIVONA
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• MDR Report Key: 11922072
• Report Number: 3012307300-2021-05403
• Device Sequence Number: 4636375
• Product Code: JOH
• UDI-Device Identifier: 15021312006063
• UDI-Public: 15021312006063
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K944178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/02/2021

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 Model Number: 670175
• Device Lot Number: 3437235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2021
• Initial Report FDA Received Date: 06/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1