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

Model Number	8LPC
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	Extubate (2402)
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, the device had air leak around the cuff.The customer indicated that the patient was re-cannulated.
Additional Manufacturer Narrative
Evaluation summary: one sample of low pressure cuffed tracheostomy tube was received for evaluation.Along with the tube one size 8 inner cannula with integral 15mm twist lock connector (white) was received for evaluation.An inflation/deflation test was performed, using a syringe 15cc of air was applied to the cuff and it was observed the cuff deflated after five minutes, the sample was submerged into a container filled with water and it was observed the tube leaked near the snap head connector, the snap head connector was removed and it was observed the inflation line presents a cut, the failure mode leak at inflation line.The device failed to meet specification as it was received or made available for evaluation.The investigation isolated the failure to the cut in the inflation line.The product relates to the reported complaint event.Information has been added to the database and trends will continue to be monitored.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: 7658816
• Report Number: 2936999-2018-00427
• Device Sequence Number: 16659895
• Product Code: JOH
• UDI-Device Identifier: 60884522007141
• UDI-Public: 60884522007141
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K962173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2019

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
• Device Catalogue Number: 8LPC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2018
• Initial Date Received by Manufacturer: 06/18/2018
• Supplement Date Received by Manufacturer: 12/04/2018
• Initial Report FDA Received Date: 07/03/2018
• Supplement Report FDA Received Date: 01/02/2019
• 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