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

Model Number	6DCT
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Extubate (2402)
Date of Event	10/30/2019
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, when they were about to remove the device and found that the clips on either side of the flange were broken.They did not slide into the patient but it extended forward about 1 to 1 1/2 inches.They remove the device and replaced it.
Additional Manufacturer Narrative
Evaluation summary: one sample was received for evaluation.The reported event was not confirmed.Additionally, a dimensional test was performed to the outer cannula holes and all the readings are according to specification.A visual inspection was conducted, and it was observed the flange is separated from the tube and it was noticed damage on both outer cannula holes and flange was missing a lug pin and was not received.A dimensional test was performed, both holes of the cannula diameters were measured.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 desarroll; ciudad juarez 32590 ; MX 32590
• MDR Report Key: 9336716
• Report Number: 2936999-2019-00950
• Device Sequence Number: 13935055
• Product Code: JOH
• UDI-Device Identifier: 20884522029015
• UDI-Public: 20884522029015
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2019

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: 6DCT
• Device Catalogue Number: 6DCT
• Device Lot Number: 18E0268JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Initial Date Received by Manufacturer: 10/31/2019
• Supplement Date Received by Manufacturer: 12/18/2019
• Initial Report FDA Received Date: 11/18/2019
• Supplement Report FDA Received Date: 12/23/2019
• 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
• Patient Age: 74 YR
• Patient Weight: 52