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

Model Number	5.0PDC
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	Extubate (2402)
Date of Event	12/09/2017
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, in 10 days of patient use an air leak occurred between the inflation line and the trach tube connection.The tube was removed and replaced.There was no patient injury.
Additional Manufacturer Narrative
One sample was received for evaluation.This product is used in treatment.An inflation/deflation test was performed and it was observed to deflate immediately.Visual inspection reveals broken inflation line at the flange connection but part of the inflation line is still attached.Product does not meet specifications.Reported event is not confirmed as related with the manufacturing process.Unit disposition is unknown.Failure was isolated to a broken inflation line, however no root cause was determined.The failure relates to the complaint event.During inflation test, air is applied through the valve on the flat pilot balloon to inflate the cuff and checked for 24 hours to make sure it is still inflated.Deflation test is performed and a vacuum system is applied through valve on the flat pilot balloon to remove the air of the cuff.All manufacturing controls were found effective to detect the reported failure mode.No corrective action is required at this time.Information has been added to the database and trends will continue to be monitored.(b)(6).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: 7203737
• Report Number: 8020889-2018-00010
• Device Sequence Number: 13682316
• Product Code: JOH
• UDI-Device Identifier: 20884522029121
• UDI-Public: 20884522029121
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K955680
• 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
• Report Date (Section B): 04/23/2018

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 Expiration Date: 01/25/2022
• Device Model Number: 5.0PDC
• Device Catalogue Number: 5.0PDC
• Device Lot Number: 17A0617JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2018
• Initial Date Received by Manufacturer: 12/22/2017
• Supplement Date Received by Manufacturer: 04/05/2018
• Initial Report FDA Received Date: 01/18/2018
• Supplement Report FDA Received Date: 04/23/2018
• 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