MAUDE Adverse Event Report: MMJ, S.A. DE C.V.(USD) SHILEY; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	10DCT
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/03/2018
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 normal procedure, the device had a dimensional issue.It was indicated that while the inner cannula was being introduced inside the tracheostomy tube, they had observed inner cannula resistance.It was stated that the inner cannula and tracheostomy tube were compatible.It was stated that there was no reported patient injury.
Additional Manufacturer Narrative
Evaluation summary: one device was received for evaluation.Failure investigator reported: a visual inspection was performed and it was observed a slight deformation on the proximal end of the cannula.The investigation isolated the failure to the dimensional issues of the product, but a cause was not identified.The product relates to the reported complaint event.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, S.A. DE C.V.(USD); ave. henequen no 1181 desarrol; ciudad juarez,ci 22225 ; MX 22225
• MDR Report Key: 7441134
• Report Number: 2936999-2018-00272
• Device Sequence Number: 1030651
• Product Code: JOH
• UDI-Device Identifier: 20884522028995
• UDI-Public: 20884522028995
• Combination Product (Y/N): N
• Initial Reporter State: PR
• Initial Reporter Country: US
• PMA/510(K) Number: K962173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2018

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: 07/25/2022
• Device Model Number: 10DCT
• Device Catalogue Number: 10DCT
• Device Lot Number: 17G0808JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2018
• Initial Date Received by Manufacturer: 04/03/2018
• Supplement Date Received by Manufacturer: 09/10/2018
• Initial Report FDA Received Date: 04/18/2018
• Supplement Report FDA Received Date: 10/01/2018
• 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: Other