MAUDE Adverse Event Report: SHILEY; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	8DCT
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Unintended Extubation (4564)
Date of Event	07/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, an audible leak was heard and patient was losing vt, a blown cuff was discovered from the patient tube.Emergency trach change was done using the same type and size of trach.The device was submerged with water to locate the leak and it was found between the trach cuff and pilot airline connection.

• Brand Name: SHILEY
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• MDR Report Key: 12678013
• Report Number: 2936999-2021-01032
• Device Sequence Number: 11775113
• Product Code: JOH
• UDI-Device Identifier: 20884522029022
• UDI-Public: 20884522029022
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K962173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/21/2021

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: 8DCT
• Device Catalogue Number: 8DCT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2021
• Initial Report FDA Received Date: 10/21/2021
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1