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

Model Number	86234
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	Extubate (2402)
Date of Event	05/18/2018
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, the patient was using the tube 8 hours prior to the incident wherein the device was noticed to be missing the 6 cm mark.It was reported that the tube was placed in the patient and was then extubated.It was suspected that the tube might have been placed incorrectly due to the missing mark.The patient was reintubated using uncuffed endotracheal tube and received mechanical ventilation.

• 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,ci 32590 ; MX 32590
• MDR Report Key: 7611163
• Report Number: 2936999-2018-00398
• Device Sequence Number: 18865634
• Product Code: BTR
• UDI-Device Identifier: 10884521212848
• UDI-Public: 10884521212848
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K151381
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/18/2018

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: 86234
• Device Catalogue Number: 86234
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2018
• Initial Report FDA Received Date: 06/18/2018
• 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