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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MMJ SA DE CV (USD) SHILEY; TUBE TRACHEOSTOMY AND TUBE CUFF
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MMJ SA DE CV (USD) SHILEY; TUBE TRACHEOSTOMY AND TUBE CUFF Back to Search Results
Model Number 8IC85
Medical Device Problem Code Physical Resistance/Sticking (4012)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 12/06/2020
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, during use, the secretions got stuck in inner cannula.Patient was ventilated with heated humidity, lots of secretions, inner cannula changed every 8 hrs.Secretions visible at the patient wye.Changing of inner cannula was very difficult to remove and required several attempts.Inner cannula was removed and replaced.
 
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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 Key11095174
Report Number2936999-2020-00991
Device Sequence Number3878369
Product Code JOH
UDI-Device Identifier10884521511934
UDI-Public10884521511934
Combination Product (Y/N)N
Initial Reporter CountryCA
PMA/510(K) Number
K142296
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 12/30/2020
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 Number8IC85
Device Catalogue Number8IC85
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/07/2020
Initial Report FDA Received Date12/30/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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