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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 96370
Medical Device Problem Code Use of Device Problem (1670)
Health Effect - Clinical Code Extubate (2402)
Date of Event 08/21/2019
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, the patient need to have the endotracheal tube (ett) changed then the cuff leaked.The doctor decided to have the patient extubated as trial and he did well.The patient had to be re-intubated and the ett failed twice.After the second failed tube, patient was placed on a bipap. he progressed well and was discharged for the hospital.
 
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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 Key9156520
Report Number2936999-2019-00824
Device Sequence Number2449262
Product Code BTR
UDI-Device Identifier40884521157461
UDI-Public40884521157461
Combination Product (Y/N)N
Initial Reporter StateWI
Initial Reporter CountryUS
PMA/510(K) Number
K941246
Number of Events Summarized1
Summary Report (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) 10/04/2019
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 Number96370
Device Catalogue Number96370
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/12/2019
Initial Report FDA Received Date10/04/2019
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 Required Intervention;
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