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

Model Number	7SCT
Health Effect - Clinical Codes	Extubate (2402); No Code Available (3191)
Date of Event	07/18/2018
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 use, the device¿s cuff did not inflate.The customer reported that the patient required re-intubation.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
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 desarrol; ciudad juarez,mx 32590 ; MX 32590
• MDR Report Key: 7746952
• Report Number: 2936999-2018-00485
• Device Sequence Number: 11092547
• Product Code: JOH
• UDI-Device Identifier: 20884522031223
• UDI-Public: 20884522031223
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K962173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/23/2018

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: 7SCT
• Device Catalogue Number: 7SCT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2018
• Initial Date Received by Manufacturer: 07/19/2018
• Supplement Date Received by Manufacturer: 08/08/2018; 09/28/2018
• Initial Report FDA Received Date: 08/03/2018
• Supplement Report FDA Received Date: 10/02/2018; 10/23/2018
• 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