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

Model Number	8DCT
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Unintended Extubation (4564)
Type of Reportable Event	Malfunction
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's tube came apart in places.Replacement of the tube was done.

• 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
• Manufacturer (Section G): MMJ SA DE CV (USD); ave henequen no 1181 desarroll; ciudad juarez 32590 ; MX 32590
• Manufacturer Contact: clay chandler ; 5920 longbow drive; boulder, CO 80301 ; 3035306409
• MDR Report Key: 13790648
• Report Number: 2936999-2022-00229
• Device Sequence Number: 19809653
• Product Code: JOH
• UDI-Device Identifier: 20884522029022
• UDI-Public: 20884522029022
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K962173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8DCT
• Device Catalogue Number: 8DCT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2022
• Initial Report FDA Received Date: 03/17/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown