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

Model Number	5.0PDC
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	Extubate (2402)
Date of Event	05/31/2018
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, during use on patient, the device had an air leaked from the cuff and the pilot balloon was easily deflated.It was reported that the device was replaced with new one but the issue was duplicated.The patient was required re-cannulation.
Additional Manufacturer Narrative
Evaluation summary: one sample of pediatric cuffed tracheostomy tube was received for evaluation.A visual inspection was performed and it was observed all the components are assembled properly at the tube.An inflation/deflation test was performed using a syringe 7cc of air was applied to the cuff.It was observed the cuff held the air.The cuff, inflation line, and pvt valve were submerged into a container filled with water and no air leaks were observed in the components.The sample was left inflated 24 hours and no deflation was observed.No failure mode was observed in the received sample since met with the product specifications and no corrective actions are required.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,ci 32590 ; MX 32590
• MDR Report Key: 7606451
• Report Number: 2936999-2018-00395
• Device Sequence Number: 11298180
• Product Code: JOH
• UDI-Device Identifier: 20884522029121
• UDI-Public: 20884522029121
• 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,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2018

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 Expiration Date: 08/30/2022
• Device Model Number: 5.0PDC
• Device Catalogue Number: 5.0PDC
• Device Lot Number: 17H1148JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2018
• Initial Date Received by Manufacturer: 05/31/2018
• Supplement Date Received by Manufacturer: 09/24/2018
• Initial Report FDA Received Date: 06/15/2018
• Supplement Report FDA Received Date: 10/18/2018
• 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