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

Model Number	6DCFS
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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, the snap lock on the inner cannula broke off.Customer reported the patient was continuing to use the same trach and there was no re-cannulation or harm.And they have switched over to another inner cannula.
Additional Manufacturer Narrative
Evaluation summary: sample was received and a visual inspection was conducted and it was observed that the flange is separated from the tube and was not received for evaluation; which would have been detected immediately in the manufacturing process since that defect is extremely obvious; therefore, the failure mode is not confirmed as related with the manufacturing process.Additionally a dimensional test was performed to the outer cannula holes and all the readings are within according to specification.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: 7494175
• Report Number: 2936999-2018-00324
• Device Sequence Number: 196518
• Product Code: JOH
• UDI-Device Identifier: 10884522006620
• UDI-Public: 10884522006620
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K962173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2018

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: 11/20/2022
• Device Model Number: 6DCFS
• Device Catalogue Number: 6DCFS
• Device Lot Number: 17K0485JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2018
• Initial Date Received by Manufacturer: 04/26/2018
• Supplement Date Received by Manufacturer: 10/19/2018
• Initial Report FDA Received Date: 05/08/2018
• Supplement Report FDA Received Date: 11/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1