MAUDE Adverse Event Report: MMJ SA DE CV (USD) SHILEY; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number	18785
Medical Device Problem Codes	Defective Component (2292); Human-Device Interface Problem (2949)
Health Effect - Clinical Codes	Adult Respiratory Distress Syndrome (1696); Pneumothorax (2012); Unintended Extubation (4564)
Date of Event	01/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Title: a case of thoracic pneumatosis due to severe coughs and tracheal tube displacement induced by tracheal tube size mismatch source: ja clinical reports, (2019) 5:8 https://doi.Org/10.1186/s40981-019-0227-0.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to literature source of clinical reports, the patient with chronic heart failure was admitted to the intensive care unit (icu) due to respiratory failure.Immediately before admission, the patient's airway was stabilized using a cuffed 8.5mm tracheal tube.The air leakage did not stop with the regular intracuff pressure (25cm h2o) due to the tracheal tube mismatch.The diameter of the patient's trachea was too large for the tube used- a diameter of 28.6mm.A higher intracuff pressure of 35cm h2o was applied to prevent air leakage and tracheal tube movement.Three days after admission, a chest x-ray showed a medial stripe sign and basilar hyperlucency indicating pneumomediastinum and pneumothorax.Patient's airway was converted to percutaneous tracheostomy.

• Brand Name: SHILEY
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): MMJ SA DE CV (USD); ave henequen no 1181 desarroll; ciudad juarez 32590 ; MX 32590
• MDR Report Key: 12005881
• Report Number: 2936999-2021-00567
• Device Sequence Number: 19909946
• Product Code: BTR
• UDI-Device Identifier: 10884522007627
• UDI-Public: 10884522007627
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K090352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/15/2021

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 Model Number: 18785
• Device Catalogue Number: 18785
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2021
• Initial Report FDA Received Date: 06/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Weight: 43