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

Model Number 85865

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/24/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event 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
• Type of Device: STYLET, TRACHEAL TUBE
• Manufacturer (Section D): COVIDIEN LP JUAREZ (MMJ); 9560 jose rodriguez drive; el paso TX 79927
• Manufacturer (Section G): COVIDIEN LP JUAREZ (MMJ); 9560 jose rodriguez drive; el paso TX 79927
• Manufacturer Contact: avi kluger ; 5920 longbow drive; boulder, CO 80301 ; 3035306582
• MDR Report Key: 11358036
• MDR Text Key: 232837464
• Report Number: 2936999-2021-00150
• Device Sequence Number: 1
• Product Code: BSR
• UDI-Device Identifier: 10884522004091
• UDI-Public: 10884522004091
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PREAMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/27/2022
• Device Model Number: 85865
• Device Catalogue Number: 85865
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1