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

Model Number	6DIC
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	Extubate (2402)
Date of Event	02/07/2018
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, during use of the device, an issue with the cannula being defective was observed.It was reported that they lock the cannula on one side, and when locking it on the other side it appeared to clip in fine, but apparently it was not catching.It was stated that when the patient coughs, the cannula comes out.The tube was removed and replaced.There was no injury and no patient symptoms or complications associated with this event.

• Brand Name: SHILEY
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): MMJ SA DE CV (USD); ave henequen no 1181 desarroll; ciudad juarez 32590 ; MX 32590
• MDR Report Key: 7302987
• Report Number: 2936999-2018-00121
• Device Sequence Number: 1328389
• Product Code: BTO
• UDI-Device Identifier: 50884522005287
• UDI-Public: 50884522005287
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K811447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/28/2018

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 Expiration Date: 12/01/2021
• Device Model Number: 6DIC
• Device Catalogue Number: 6DIC
• Device Lot Number: 16L0041JZX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2018
• Initial Report FDA Received Date: 02/28/2018
• 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