MAUDE Adverse Event Report: MMJ SA DE CV (USD) SHILEY; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	10DCT
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/16/2019
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, during procedure, the device cuff had inflation/deflation issue.There was no patient injury.
Additional Manufacturer Narrative
Additional information: d10, g4, h3, h6 h3.Evaluation summary: one sample of device was received for evaluation.An inflation /deflation test was performed.A visual inspection was performed and it was observed the cuff presents a small cut.The reported event was confirmed.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.

• Brand Name: SHILEY
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): MMJ SA DE CV (USD); ave henequen no 1181 desarroll; ciudad juarez,mx 32590 ; MX 32590
• MDR Report Key: 9563562
• Report Number: 2936999-2020-00034
• Device Sequence Number: 2902208
• Product Code: JOH
• UDI-Device Identifier: 20884522028995
• UDI-Public: 20884522028995
• Combination Product (Y/N): N
• Initial Reporter Country: PA
• PMA/510(K) Number: K962173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2020

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: 07/23/2024
• Device Model Number: 10DCT
• Device Catalogue Number: 10DCT
• Device Lot Number: 19G0768JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2020
• Initial Date Received by Manufacturer: 12/19/2019
• Supplement Date Received by Manufacturer: 05/08/2020
• Initial Report FDA Received Date: 01/08/2020
• Supplement Report FDA Received Date: 05/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR