MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA TTS NEONATAL/PEDIATRIC TRACHEOSTOMY TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number	67SN030
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/04/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the device was placed in use with patient but did not fully inflate on both sides of the cuff.The device was removed and replaced to continue ventilation.No further adverse effects reported.

• Brand Name: BIVONA TTS NEONATAL/PEDIATRIC TRACHEOSTOMY TUBE
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• MDR Report Key: 10797422
• Report Number: 3012307300-2020-11064
• Device Sequence Number: 3015927
• Product Code: JOH
• UDI-Device Identifier: 15021312000245
• UDI-Public: 15021312000245
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K914088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/06/2020

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: 67SN030
• Device Catalogue Number: 67SN030
• Device Lot Number: 3585070
• 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: 10/06/2020
• Initial Report FDA Received Date: 11/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 8 MO
• Patient Weight: 4