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

Model Number	6DCFS
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: health professional (hpro).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 inner cannula extends past tracheostomy cannula by 4 to 6 millimeter.It was reported that there was no patient involvement.
Additional Manufacturer Narrative
Evaluation summary: one sample was received for evaluation.No failure was confirmed.A dimensional test was performed, the inner cannula was inserted inside the outer cannula, and it was observed the distal end of the inner cannula protruded 0.065 inches out of the outer cannula, this protrusion is within specification.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: 7832400
• Report Number: 2936999-2018-00549
• Device Sequence Number: 1229212
• Product Code: JOH
• UDI-Device Identifier: 10884522006620
• UDI-Public: 10884522006620
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K962173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2018

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 Expiration Date: 02/23/2022
• Device Model Number: 6DCFS
• Device Catalogue Number: 6DCFS
• Device Lot Number: 17B0585JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2018
• Initial Date Received by Manufacturer: 08/13/2018
• Supplement Date Received by Manufacturer: 11/15/2018
• Initial Report FDA Received Date: 08/30/2018
• Supplement Report FDA Received Date: 12/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1