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

Model Number	8LPC-S
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	Extubate (2402)
Date of Event	08/01/2018
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 tracheostomy tube had cuff inflation/deflation issue for size 8 tube.The customer reported that the tracheostomy tube was tested prior to be blowing the cuff to 15 cmh20 and checked with a pressure gauge.The customer also reported that the patient was reintubated.It was indicated that the patient remained in (b)(6) icu((b)(6), intensive care unit) and the tracheostomy tube was changed in size 7xl due to ongoing cuff leak with the size 8.

• 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: 7889355
• Report Number: 2936999-2018-00594
• Device Sequence Number: 1908677
• Product Code: JOH
• UDI-Device Identifier: 20884522031988
• UDI-Public: 20884522031988
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 09/19/2018

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: 8LPC-S
• Device Catalogue Number: 8LPC-S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2018
• Initial Report FDA Received Date: 09/19/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 35 YR