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

Model Number	10DFEN
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 tube began to fail and would not hold any inflation even if it was used before approaching 28 days.The customer reported that the patient was required to be re-cannulated.
Additional Manufacturer Narrative
Evaluation summary: one sample was received for analysis and the reported issue was confirmed.An inflation/deflation test was performed and using a syringe, 18 cc of air was applied to the cuff and it was observed the cuff deflated after a few seconds, the sample was submerged into a container filled with water and it was observed the cuff leaked from several small cuts, the failure mode cut in cuff is confirmed.The device history record (dhr) was reviewed and no discrepancies were found.Manufacturing controls are in place to detect damage and to reduce the potential for occurrence during the manufacturing process.The damage observed in the sample would have been detected during the manufacturing process.Information has been added to the database and complaint 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 desarroll; ciudad juarez,ci 32590 ; MX 32590
• MDR Report Key: 7434892
• Report Number: 2936999-2018-00264
• Device Sequence Number: 10822674
• Product Code: JOH
• UDI-Device Identifier: 50884522006567
• UDI-Public: 50884522006567
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K962173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2018

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: 10DFEN
• Device Catalogue Number: 10DFEN
• Device Lot Number: 17EO569JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2018
• Initial Date Received by Manufacturer: 04/02/2018
• Supplement Date Received by Manufacturer: 05/10/2018
• Initial Report FDA Received Date: 04/16/2018
• Supplement Report FDA Received Date: 05/18/2018
• 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