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

Model Number	6LPC
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the device¿s cuff would not stay inflated.There was no patient harm.
Additional Manufacturer Narrative
Evaluation summary: one sample was received for evaluation.The failure inflation line leak 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.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: 8300569
• Report Number: 2936999-2019-00085
• Device Sequence Number: 154972
• Product Code: JOH
• UDI-Device Identifier: 60884522007134
• UDI-Public: 60884522007134
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K962173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2019

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: 11/21/2022
• Device Model Number: 6LPC
• Device Catalogue Number: 6LPC
• Device Lot Number: 17K0592JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2019
• Initial Date Received by Manufacturer: 01/11/2019
• Supplement Date Received by Manufacturer: 02/12/2019
• Initial Report FDA Received Date: 02/03/2019
• Supplement Report FDA Received Date: 03/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1