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

Model Number	4.5PDC
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Extubate (2402)
Date of Event	10/31/2019
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 inflation line was disconnected from the tube around 20 days after exchange.The patient was reintubated for periodic exchange to solve the problem.
Additional Manufacturer Narrative
Evaluation summary: one sample device was received for evaluation and the reported issue was not confirmed.An inflation/deflation test was performed, air is applied through valve on pilot balloon to inflate the cuff and checked to make sure that the cuff is still inflated.A vacuum system is applied through valve on pilot balloon to remove the air of the cuff.A visual inspection was performed and it was observed the inflation line is detached from the tube, inside the flange connector there is a piece of the inflation line bonded.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); 9560 jose rodriguez drive; el paso TX 79927
• MDR Report Key: 9380215
• Report Number: 2936999-2019-00974
• Device Sequence Number: 3103657
• Product Code: JOH
• UDI-Device Identifier: 20884522029114
• UDI-Public: 20884522029114
• 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: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2020

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: 4.5PDC
• Device Catalogue Number: 4.5PDC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Initial Date Received by Manufacturer: 11/11/2019
• Supplement Date Received by Manufacturer: 01/31/2020
• Initial Report FDA Received Date: 11/26/2019
• Supplement Report FDA Received Date: 02/17/2020
• 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