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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 18765S
Medical Device Problem Code Gas/Air Leak (2946)
Health Effect - Clinical Code Extubate (2402)
Date of Event 01/22/2020
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, during use, the device had leak.Extubation and re-intubation were performed and the issue was resolved.The product was checked after extubation, the tube tip was closed and was placed in water.When the pressure was applied from the slip joint part, bubbles came out from the root part of the inflation line.The hole part that was opened to attach the inflation line to the tube was being penetrated.
 
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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 Key9667399
Report Number2936999-2020-00094
Device Sequence Number19618397
Product Code BTR
UDI-Device Identifier10884521164543
UDI-Public10884521164543
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K090352
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional,u
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 02/04/2020
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 Number18765S
Device Catalogue Number18765S
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/22/2020
Initial Report FDA Received Date02/04/2020
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 Required Intervention;
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