MAUDE Adverse Event Report: SHILEY; STYLET, TRACHEAL TUBE

Model Number	85864
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2021
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, during use of the device, the thread was very malleable.Anesthesiologist tried it three times because it bent together with wire tube.There was no patient injury.

• Brand Name: SHILEY
• Common Device Name: STYLET, TRACHEAL TUBE
• MDR Report Key: 11614078
• Report Number: 2936999-2021-00304
• Device Sequence Number: 3049178
• Product Code: BSR
• UDI-Device Identifier: 10884522004084
• UDI-Public: 10884522004084
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/05/2021

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: 08/21/2022
• Device Model Number: 85864
• Device Catalogue Number: 85864
• Device Lot Number: 17H0613JZX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2021
• Initial Report FDA Received Date: 04/05/2021
• Date Device Manufactured: 08/22/2017
• 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