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

Model Number 86452

Device Problem Use of Device Problem (1670)

Patient Problem Injury (2348)

Event Date 11/02/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the reporter, there were cuff failure on 4 units.It was stated that there was a delay in procedure/surgery and the patient was injured.

• Brand Name: SHILEY
• Type of Device: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): MMJ SA DE CV (USD); 9560 jose rodriguez drive; el paso TX 79927
• Manufacturer (Section G): MMJ SA DE CV (USD); 9560 jose rodriguez drive; el paso TX 79927
• Manufacturer Contact: avi kluger ; 5920 longbow drive; boulder, CO 80301 ; 3035306582
• MDR Report Key: 9446141
• MDR Text Key: 170107538
• Report Number: 2936999-2019-01010
• Device Sequence Number: 1
• Product Code: BTR
• UDI-Device Identifier: 10884522000482
• UDI-Public: 10884522000482
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K965132
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/04/2024
• Device Model Number: 86452
• Device Catalogue Number: 86452
• Device Lot Number: 19B0118JZX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/24/2019
• Date Device Manufactured: 02/05/2019
• 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): Other