MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA TTS NEONATAL /PEDIATRIC TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUF

Model Number	67SN035
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hypoventilation (1916)
Date of Event	08/30/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the device was being placed in use with patient.The reporter stated the cuff would not inflate symmetrically.The reporter stated this issue caused "difficulties with ventilation" with patient and tracheostomy tube had to be removed and replaced to continue ventilation.No further adverse effects to patient reported.
Event or Problem Description
Additional information provided (b)(6): added to operator details to section d5 and contact details to sections e2 and e3.
Additional Manufacturer Narrative
Device evaluation: one decontaminated sample was received without its original packaging in used condition.Functional testing involved an air cuff symmetry test.When the unit was inflated with air, the cuff only inflated on one side.When the cuff was manipulated the whole cuff inflated.The cuff was subsequently deflated and inflated an additional four times and each time it inflated completely.The measurement of the cuff, the percentage for symmetry, was found to be within manufacturing specifications.Based on the investigation, the complaint allegation was not confirmed.

• Brand Name: BIVONA TTS NEONATAL /PEDIATRIC TRACHEOSTOMY TUBE
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• MDR Report Key: 10805044
• Report Number: 3012307300-2020-11154
• Device Sequence Number: 3569474
• Product Code: JOH
• UDI-Device Identifier: 15021312000252
• UDI-Public: 15021312000252
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K914088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/21/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/03/2022
• Device Model Number: 67SN035
• Device Catalogue Number: 67SN035
• Device Lot Number: 3437795
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 12/14/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/08/2020
• Supplement Date Received by Manufacturer: 11/23/2020; 12/27/2020
• Initial Report FDA Received Date: 11/06/2020
• Supplement Report FDA Received Date: 12/18/2020; 01/21/2021
• 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: Life Threatening; Required Intervention
• Patient Age: 25 MO