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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MMJ SA DE CV (USD) SHILEY; TUBE, TRACHEAL (W/WO CONNECTOR)
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MMJ SA DE CV (USD) SHILEY; TUBE, TRACHEAL (W/WO CONNECTOR) Back to Search Results
Model Number 86453
Medical Device Problem Code Material Split, Cut or Torn (4008)
Health Effect - Clinical Code Insufficient Information (4580)
Type of Reportable Event Death
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 had cuff breakage.Patients had been intubated, it was mentioned that it was a covid patient in critical care with co-morbidities.It was indicated that they taken off the vent at the request of the family due to the severity of condition and other co-morbidities that the patient had and died as a result.
 
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Brand Name
SHILEY
Common Device Name
TUBE, TRACHEAL (W/WO CONNECTOR)
Manufacturer (Section D)
MMJ SA DE CV (USD)
ave henequen no 1181 desarroll
ciudad juarez 32590
MX  32590
MDR Report Key10861054
Report Number2936999-2020-00878
Device Sequence Number3803102
Product Code BTR
UDI-Device Identifier30884522000493
UDI-Public30884522000493
Combination Product (Y/N)N
Initial Reporter StateVA
Initial Reporter CountryUS
PMA/510(K) Number
K965132
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 11/18/2020
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 Number86453
Device Catalogue Number86453
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/30/2020
Initial Report FDA Received Date11/18/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Death; Required Intervention;
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