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

Model Number	4.0PDC
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	Extubate (2402)
Date of Event	03/28/2019
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, there was a leakage in the unit.They replaced the tracheostomy tube.When they immersed the tube in water, water bubbles came out of the inflation line.
Event or Problem Description
According to the reporter, during use, there was a leakage in the unit.It was reported that they replaced the tracheostomy tube.When they immersed the tube in water, water bubbles came out of the inflation line.
Additional Manufacturer Narrative
Evaluation summary: one sample of device was received for evaluation, no lot number was provided.An inflation/deflation test was performed and it was observed the flange connector leaks through the connection of the inflation line.The reported event was confirmed.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: 8526980
• Report Number: 2936999-2019-00285
• Device Sequence Number: 1885133
• Product Code: JOH
• UDI-Device Identifier: 20884522029107
• UDI-Public: 20884522029107
• 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: distributor,foreign,health pr
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2019

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: 4.0PDC
• Device Catalogue Number: 4.0PDC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2019
• Initial Date Received by Manufacturer: 03/28/2019
• Supplement Date Received by Manufacturer: 08/29/2019
• Initial Report FDA Received Date: 04/18/2019
• Supplement Report FDA Received Date: 09/24/2019
• 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