MAUDE Adverse Event Report: SHILEY; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number	SSV
Medical Device Problem Code	Ambient Noise Problem (2877)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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, the product had a clicking noise during use.There was no patient injury.

• Brand Name: SHILEY
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• MDR Report Key: 11987841
• Report Number: 2936999-2021-00533
• Device Sequence Number: 11619445
• Product Code: BTO
• UDI-Device Identifier: 40884522005365
• UDI-Public: 40884522005365
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K945406
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/11/2021

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 Expiration Date: 01/29/2026
• Device Model Number: SSV
• Device Catalogue Number: SSV
• Device Lot Number: 21A1019JZX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2021
• Initial Report FDA Received Date: 06/11/2021
• Date Device Manufactured: 01/29/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1