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	No Patient Involvement (2645)
Date of Event	01/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, prior to use, the cuff did not inflate.The customer reported there was no patient involvement.
Additional Manufacturer Narrative
Evaluation summary: one sample of device was received for evaluation.A visual inspection was performed and it was observed all the components are assembled properly at the tube according to drawing.An inflation/deflation test was performed.Air was applied to the cuff, and it was observed the cuff the cuff held the air.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 desarrol; ciudad juarez,mx 32590 ; MX 32590
• MDR Report Key: 8337003
• Report Number: 2936999-2019-00118
• Device Sequence Number: 1357553
• 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: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2019

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 Model Number: 5.0PDC
• Device Catalogue Number: 5.0PDC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2019
• Initial Date Received by Manufacturer: 01/21/2019
• Supplement Date Received by Manufacturer: 05/20/2019
• Initial Report FDA Received Date: 02/13/2019
• Supplement Report FDA Received Date: 06/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1