MAUDE Adverse Event Report: COVIDIEN LP JUAREZ (MMJ) SHILEY; STYLET, TRACHEAL TUBE

Model Number	85865
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2020
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 intubation, the device did not provide normal rigidity to ett.It was indicated that the stylet was more malleable than typical.There was no patient injury.

• Brand Name: SHILEY
• Common Device Name: STYLET, TRACHEAL TUBE
• Manufacturer (Section D): COVIDIEN LP JUAREZ (MMJ); 9560 jose rodriguez drive; el paso TX 79927
• MDR Report Key: 11358036
• Report Number: 2936999-2021-00150
• Device Sequence Number: 19030070
• Product Code: BSR
• UDI-Device Identifier: 10884522004091
• UDI-Public: 10884522004091
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: PREAMEND
• 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): 02/22/2021

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: 07/27/2022
• Device Model Number: 85865
• Device Catalogue Number: 85865
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2021
• Initial Report FDA Received Date: 02/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1