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

Model Number	18785
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/31/2020
Type of Reportable Event	Malfunction
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 device's cuff was blown during use.There was no patient injury.
Additional Manufacturer Narrative
Additional information: b5, d3 (street 1, mfr city, mfr region, country code, postal code), g4, h3 h3 evaluation summary: pictures were received for evaluation.The reported event could not be confirmed.Without a sample is unable to perform a thorough follow up investigation to include functional and visual evaluation to determine the root cause of the reported condition or implement any corrective action.Information has been added to the database and trends will continue to be monitored.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the device's cuff was blown during use.Patient was alert.There was no patient injury.

• Brand Name: SHILEY
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): MMJ SA DE CV (USD); 9560 jose rodriguez drive; el paso TX 79927
• MDR Report Key: 9968179
• Report Number: 2936999-2020-00282
• Device Sequence Number: 4356291
• Product Code: BTR
• UDI-Device Identifier: 10884522007627
• UDI-Public: 10884522007627
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K090352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/25/2024
• Device Model Number: 18785
• Device Catalogue Number: 18785
• Device Lot Number: 19B0922JZX
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/02/2020
• Supplement Date Received by Manufacturer: 04/27/2020
• Initial Report FDA Received Date: 04/16/2020
• Supplement Report FDA Received Date: 05/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1