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

Model Number	6SCT
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Extubate (2402)
Date of Event	12/20/2019
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 use, the device balloon keep deflating.Some tests were done and it was found out that the problem was occurring when the inner cannula came out where it make a smooth curve.When inverting the curve to the opposite side, the cuff remained for more than an inflated top and when it returned to the correct place, it emptied immediately.The patient had a change in respiratory rate and was recannulated.
Additional Manufacturer Narrative
Additional information: d10, g4, h3, h6 h3 evaluation summary: two photos were provided for evaluation.The reported event was not confirmed.One of the photos shows the cuff inflated and the second photo shows the cuff deflated, no damages are observed in the cuff and inflation line.There is not possible to identify the leak issue without the sample.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: 9653475
• Report Number: 2936999-2020-00072
• Device Sequence Number: 2860489
• Product Code: JOH
• UDI-Device Identifier: 20884522031216
• UDI-Public: 20884522031216
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 06/08/2020

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: 11/21/2023
• Device Model Number: 6SCT
• Device Catalogue Number: 6SCT
• Device Lot Number: 18K0482JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2020
• Initial Date Received by Manufacturer: 01/20/2020
• Supplement Date Received by Manufacturer: 05/21/2020
• Initial Report FDA Received Date: 01/31/2020
• Supplement Report FDA Received Date: 06/08/2020
• 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: Life Threatening; Required Intervention
• Patient Age: 33 YR
• Patient Weight: 60