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

Model Number	3.0NEO
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Extubate (2402)
Date of Event	09/10/2018
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 the change of tracheostomy tube, the insertion was very painful due to the thick and rigid material.It was also stated that the device needed more pressure to be applied which may also be the reason of the problem.The patient was re-intubated.After a third attempt to introduce the 3rd cannula, a cannula of a different lot number was used without issue.In subsequent insertion of 2 cannulas of the reported lot number, the painfulness and suffocation status were repeated.Also, by checking and by touch control she could feel the difference of the material.The patient has had a permanent tracheostomy for more than 2 years that requires very often changes of tubes.The usage of the tracheostomy tubes is on a regular basis.
Additional Manufacturer Narrative
Evaluation summary: a fourth sample received for evaluation.No reported event was observed since met with the product specifications.A visual inspection was performed, and it was observed all the components are assembled properly at the tube.A dimensional test was performed in outer and inner diameter of the cannula, these reading is within specification.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 32590 ; MX 32590
• MDR Report Key: 8367316
• Report Number: 2936999-2019-00137
• Device Sequence Number: 1734129
• Product Code: JOH
• UDI-Device Identifier: 30884522026653
• UDI-Public: 30884522026653
• Combination Product (Y/N): N
• Initial Reporter Country: LO
• PMA/510(K) Number: K945513
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2019

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: 02/23/2020
• Device Model Number: 3.0NEO
• Device Catalogue Number: 3.0NEO
• Device Lot Number: 15B0657JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2019
• Initial Date Received by Manufacturer: 12/07/2018
• Supplement Date Received by Manufacturer: 06/13/2019
• Initial Report FDA Received Date: 02/25/2019
• Supplement Report FDA Received Date: 06/19/2019
• 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
• Patient Age: 4 YR