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

Model Number	6DFEN
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	Extubate (2402)
Date of Event	08/30/2018
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 unit had a leak.The customer stated the patient was intubated.
Additional Manufacturer Narrative
Evaluation summary: one sample was received for evaluation.The device history record was reviewed and no discrepancies were found.The failure mode tear in cuff was confirmed in the received sample.Manufacturing process was reviewed and currently, there is no potential risk and the below conditions were found: inflation test ¿ air is applied through valve on the flat pilot balloon to inflate the cuff.The cuff is checked at 24 hours to make sure that the cuff is still inflated.A deflation test is performed; a vacuum system is applied through valve on the flat pilot balloon to remove the air of the cuff.All manufacturing controls were found effective and properly implemented to detect the reported failure mode.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 desarrol; ciudad juarez,mx 32590 ; MX 32590
• MDR Report Key: 7951506
• Report Number: 2936999-2018-00628
• Device Sequence Number: 16431773
• Product Code: JOH
• UDI-Device Identifier: 50884522006642
• UDI-Public: 50884522006642
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K962173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2018

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 Model Number: 6DFEN
• Device Catalogue Number: 6DFEN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2018
• Initial Date Received by Manufacturer: 09/12/2018
• Supplement Date Received by Manufacturer: 11/06/2018
• Initial Report FDA Received Date: 10/10/2018
• Supplement Report FDA Received Date: 12/04/2018
• 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: 75 YR