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

Model Number	18775S
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Pulmonary Emphysema (1832)
Date of Event	10/27/2020
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, at day 5 of intubation, there was appearance of cervical emphysema with pneumomediastinum which was objectified by a chest scanner.Intubation was performed by a senior doctor.Ras during the gesture.With the use of a replacement tube, there was presence of an unused stylet replaced by a disposable stylet (glidescope).The mechanical ventilation was disturbed, pressure build-up, hypercapnia and ventilator leaks as consequence.There was no extubation because the patient was not sufficiently stable, regression probable under drainage.Complete evolution unknown.

• Brand Name: TAPERGUARD
• 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: 10829106
• Report Number: 2936999-2020-00862
• Device Sequence Number: 4177794
• Product Code: BTR
• UDI-Device Identifier: 10884521103856
• UDI-Public: 10884521103856
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K090352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/12/2020

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: 18775S
• Device Catalogue Number: 18775S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2020
• Initial Report FDA Received Date: 11/12/2020
• 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: 70 YR