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

Model Number	5.0 PED
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/26/2018
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, while in use on a patient, the tubing was fixed with two hand made band with fringe, the fringe was broken and the band was detached.There was no patient harm.
Additional Manufacturer Narrative
Evaluation summary: the sample was received for analysis and the reported issue was confirmed.The reported customer event is a known issue and root cause investigation efforts have been addressed in a corrective and preventative action.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.
Additional Manufacturer Narrative
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: 7673458
• Report Number: 2936999-2018-00435
• Device Sequence Number: 19195475
• Product Code: JOH
• UDI-Device Identifier: 30884522026738
• UDI-Public: 30884522026738
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K945513
• 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,Followup
• Report Date (Section B): 10/26/2018

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: 5.0 PED
• Device Catalogue Number: 5.0 PED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2018
• Initial Date Received by Manufacturer: 06/25/2018
• Supplement Date Received by Manufacturer: 08/08/2018; 09/28/2018
• Initial Report FDA Received Date: 07/10/2018
• Supplement Report FDA Received Date: 10/03/2018; 10/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1