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

Model Number	10CFN
Medical Device Problem Code	Split (2537)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/29/2018
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, during use, the device was difficult to remove and once removed, a piece of plastic white broke.The customer indicated that there was no patient injury.
Additional Manufacturer Narrative
Additional information: evaluation summary: the sample was received for analysis and the reported issue was confirmed.Procedure was done to inspect the product taking as aql of 2.5 every one hour and half using a sampling plan.This quality instruction describes the guidelines to verify the head for damages and head seated.Device history record was not reviewed since the lot number was not provided.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.; ave. henequen no 1181 desarrol; ciudad juarez,ci 32590 ; MX 32590
• MDR Report Key: 7454772
• Report Number: 2936999-2018-00289
• Device Sequence Number: 1373628
• Product Code: JOH
• UDI-Device Identifier: 50884522006901
• UDI-Public: 50884522006901
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 08/10/2018

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 Model Number: 10CFN
• Device Catalogue Number: 10CFN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2018
• Initial Date Received by Manufacturer: 04/11/2018
• Supplement Date Received by Manufacturer: 07/26/2018
• Initial Report FDA Received Date: 04/24/2018
• Supplement Report FDA Received Date: 08/10/2018
• 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: Required Intervention
• Patient Age: 78 YR
• Patient Weight: 68