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

Model Number	5.0PLC
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Extubate (2402)
Date of Event	01/17/2020
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 tube exchange, leakage occurred.It was reported that after they checked the cuff pressure as usual, the situation was still the same.When the tube was replaced with a new tube, the problem was solved.When the cuff of the defective product was checked, it was found to ruck up easier compared to the usual.
Additional Manufacturer Narrative
Additional information: d10, g4, h3, h6 h3 evaluation summary: one device was received for evaluation.The reported event was not confirmed.The device met with product specification.A visual in spection was performed and it was observed all the components are assembled properly at the tube.An inflation/deflation test was performed and no leaks were observed.No failure mode was observed in the received 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: 9647853
• Report Number: 2936999-2020-00069
• Device Sequence Number: 10863008
• Product Code: JOH
• UDI-Device Identifier: 20884522029039
• UDI-Public: 20884522029039
• 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,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2020

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: 07/23/2024
• Device Model Number: 5.0PLC
• Device Catalogue Number: 5.0PLC
• Device Lot Number: 19G0755JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2020
• Initial Date Received by Manufacturer: 01/17/2020
• Supplement Date Received by Manufacturer: 03/04/2020
• Initial Report FDA Received Date: 01/30/2020
• Supplement Report FDA Received Date: 03/20/2020
• 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: Required Intervention