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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MMJ SA DE CV (USD) MALLINCKRODT; TUBE, TRACHEAL (W/WO CONNECTOR)
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MMJ SA DE CV (USD) MALLINCKRODT; TUBE, TRACHEAL (W/WO CONNECTOR) Back to Search Results
Model Number 18870
Medical Device Problem Code Inflation Problem (1310)
Health Effect - Clinical Code Extubate (2402)
Date of Event 10/26/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
Medtronic received a communication regarding a cuff inflation/deflation issue.The customer indicated that the device was removed due to the cuff inflation/deflation issue but there were no further injury associated with this event.
 
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Brand Name
MALLINCKRODT
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 Key7034229
Report Number2936999-2017-05616
Device Sequence Number1358377
Product Code BTR
UDI-Device Identifier20884521032528
UDI-Public20884521032528
Combination Product (Y/N)N
Initial Reporter CountryCH
PMA/510(K) Number
K090352
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2017
Reporter Type Manufacturer
Report Source foreign,health professional,u
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 11/15/2017
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 Expiration Date01/18/2022
Device Model Number18870
Device Catalogue Number18870
Device Lot Number17A0359JZX
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/27/2017
Initial Report FDA Received Date11/15/2017
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;
Patient Age52 YR
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