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

Model Number	6.5PLC
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	Extubate (2402)
Date of Event	06/11/2018
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, when the device was checked by cuff pressure gauge, the air did not enter the cuff.It was reported that after extubation, it was confirmed that the air entered the cuff.
Additional Manufacturer Narrative
Evaluation summary: the sample was received for evaluation and an inflation/deflation test was performed using a syringe.9cc of air was applied to the cuff, and it was observed the cuff held the air and no difficulties were noticed at the time of inflation nor deflation, the sample was left inflated 24 hours and no leaks were observed.Additionally, the cuff, inflation line and valve were submerged into a container filled with water and no leaks were observed.No failure mode was observed in the received sample, and all manufacturing controls were found acceptable and effective 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: 7637703
• Report Number: 2936999-2018-00412
• Device Sequence Number: 1946270
• Product Code: JOH
• UDI-Device Identifier: 20884522029060
• UDI-Public: 20884522029060
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K955680
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2018

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: 6.5PLC
• Device Catalogue Number: 6.5PLC
• Device Lot Number: 17E854JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2018
• Initial Date Received by Manufacturer: 06/11/2018
• Supplement Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 06/26/2018
• Supplement Report FDA Received Date: 09/21/2018
• 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