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, the device had probably a thick and rigid material that caused a very painful insertion.It was also stated that the device was applied with bigger pressure, which also the reason of the problem.The customer indicated that the patient was re-intubated.
Additional Manufacturer Narrative
Evaluation summary: one sample was 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 according to drawing, a dimensional test was performed outer and inner diameter of the cannula was measured, this 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.
Event or Problem Description
According to the reporter, during the change of tracheostomy tube, the insertion of the cannula was very painful due to the thick and rigid material.The device needed more pressure to be applied which may also be the reason of the problem.The patient was re-cannulated.Additional information indicates that 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 over 2 years, the usage of the tracheostomy tubes is on a regular basis and requires very often changes of tubes.

• Brand Name: SHILEY
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): MMJ SA DE CV(USD); ave henequen no 1181 desarrol; ciudad juarez,mx 32590 ; MX 32590
• MDR Report Key: 7951434
• Report Number: 2936999-2018-00626
• Device Sequence Number: 203329
• 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: foreign,other,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2019

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: 05/08/2019
• Initial Date Received by Manufacturer: 09/12/2018
• Supplement Date Received by Manufacturer: 06/13/2019
• Initial Report FDA Received Date: 10/10/2018
• Supplement Report FDA Received Date: 06/21/2019
• 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