MAUDE Adverse Event Report: MMJ SA DE CV (USD) SHILEY; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	8DCT
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Low Oxygen Saturation (2477); Unintended Extubation (4564)
Date of Event	02/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, a patient went to the operation room for a tracheostomy due to severe covid and respiratory failure.During trach placement, the tracheostomy was placed and the tracheostomy was noted to be down after inflation and there was concern for a damaged cuff.Given that the cuff was torn the patient was re-intubated with endotracheal tube (ett) that was still in upper trachea and the tracheostomy was removed.The patient then recovered as the patient had very poor pulmonary reserve and a new tracheostomy was placed.This cuff was checked prior to placement but again was torn following placement.The patient's spo2 remained at 95% and a new tracheostomy was prepared to be placed.When awaiting a new tracheostomy the patient was noted to lose spo2 and go into ventricular fibrillation.The ett was again placed and the tracheostomy with broken cuff was removed.Advance cardiovascular life support (acls) commenced and the patient underwent multiple rounds of cardiopulmonary resuscitation (cpr).After cpr was commenced last t ime, the patient then began to have massive hemoptysis from her ett with inability to ventilate.Resuscitative efforts ceased after discussion with the team.

• Brand Name: SHILEY
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): MMJ SA DE CV (USD); ave henequen no 1181 desarroll; ciudad juarez 32590 ; MX 32590
• Manufacturer (Section G): MMJ SA DE CV (USD); ave henequen no 1181 desarroll; ciudad juarez 32590 ; MX 32590
• Manufacturer Contact: clay chandler ; 5920 longbow drive; boulder, CO 80301 ; 3035306409
• MDR Report Key: 14490208
• Report Number: 2936999-2022-00455
• Device Sequence Number: 4680708
• Product Code: JOH
• UDI-Device Identifier: 20884522029022
• UDI-Public: 20884522029022
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K962173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/22/2024
• Device Model Number: 8DCT
• Device Catalogue Number: 8DCT
• Device Lot Number: 19J0686JZX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2022
• Initial Report FDA Received Date: 05/24/2022
• Date Device Manufactured: 10/24/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female