MAUDE Adverse Event Report: SHILEY; STYLET, TRACHEAL TUBE

Model Number	85864
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/29/2021
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, the device had a very malleable thread.The anesthesiologist had to try it 3 times because it even folded together with a wire tube.There was no reported patient involvement or outcome.

• Brand Name: SHILEY
• Common Device Name: STYLET, TRACHEAL TUBE
• MDR Report Key: 11627685
• Report Number: 2936999-2021-00332
• Device Sequence Number: 3496038
• 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
• Type of Report: Initial
• Report Date (Section B): 04/07/2021

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: 03/18/2021
• Initial Report FDA Received Date: 04/07/2021
• 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