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

Model Number 6DIC

Device Problem Connection Problem (2900)

Patient Problem Extubate (2402)

Event Date 02/07/2018

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event 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
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• 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: sharon murphy ; 15 hampshire street; mansfield, MA 02048 ; 2034925267
• MDR Report Key: 7302987
• MDR Text Key: 101162315
• Report Number: 2936999-2018-00121
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 50884522005287
• UDI-Public: 50884522005287
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K811447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 02/07/2018
• Initial Date FDA Received: 02/28/2018
• Date Device Manufactured: 12/02/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention