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

Model Number	67SP035
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/21/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that a smiths medical trach was having issues recently.After massaging the cuff, the cuff was not inflating properly.When the water is in the pilot balloon it appears to be full and the cuff initially inflates parts way but when the syringe is removed it deflates but the pilot stays inflated.The trach in the patient deflated.There were no reported adverse events.
Additional Manufacturer Narrative
Other text: investigation completed on a smiths intubation|portex endotracheal tubes.Sample inspected at 12? to 16? and normal conditions of illumination with no discrepancies noted.During functional testing results: when we inflated the unit with air, the cuff only inflated one side.According to the ifu (10018853-001 rev.100 - ifu - pedi/neo tts (pnt)) we manipulated the pilot balloon and the cuff inflated but only one side, we manipulated the cuff and the whole cuff inflated.The cuff was then inflated four times with air and no discrepancies were noted.The quality review was attached and revealed no discrepancies prior to release, as this preformed 100% no fault found and no corrective actions were taken.
Event or Problem Description
Device evaluation completed and will be summarized in h10.

• Brand Name: BIVONA
• Common Device Name: TRACHEOSTOMY TUBE AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• MDR Report Key: 10541519
• Report Number: 3012307300-2020-09391
• Device Sequence Number: 2803312
• Product Code: JOH
• UDI-Device Identifier: 15021312000719
• UDI-Public: 15021312000719
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K914088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 67SP035
• Device Lot Number: 3926976
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/21/2020
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 09/16/2020
• Supplement Report FDA Received Date: 11/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 5