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

Model Number	4IC65
Medical Device Problem Codes	Break (1069); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary one product was received for evaluation.The device failed to meet specification as it was received or made available for evaluation by the sales rep.The investigation isolated the failure to the usability of the device, but a cause was not identified.The product relates to the reported complaint event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the unit had an unknown failure.There was no reported patient involvement and outcome.
Event or Problem Description
According to the reporter, during inspection of the device, a manual pinching of the inner cannula resulted in a crease in the cannula and a cracking sound was heard.There was no reported patient involvement and outcome.
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 32590 ; MX 32590
• MDR Report Key: 8248412
• Report Number: 2936999-2019-00058
• Device Sequence Number: 2190395
• Product Code: JOH
• UDI-Device Identifier: 10884521511972
• UDI-Public: 10884521511972
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K142298
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2019

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: 4IC65
• Device Catalogue Number: 4IC65
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2016
• Initial Date Received by Manufacturer: 03/20/2017
• Supplement Date Received by Manufacturer: 03/20/2017
• Initial Report FDA Received Date: 01/15/2019
• Supplement Report FDA Received Date: 01/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1