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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 18760
Medical Device Problem Code Material Discolored (1170)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 08/20/2018
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, the device had a different tube color which is pink compared from the other tubes.The customer indicated no patient involvement.
 
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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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 desarrol
ciudad juarez,mx 32590
MX  32590
MDR Report Key7856622
Report Number2936999-2018-00568
Device Sequence Number1565483
Product Code BTR
UDI-Device Identifier50884522007571
UDI-Public50884522007571
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 distributor,foreign,user faci
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 12/20/2018
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 Expiration Date07/27/2021
Device Model Number18760
Device Catalogue Number18760
Device Lot Number16G0676JZX
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/10/2018
Initial Date Received by Manufacturer 08/21/2018
Supplement Date Received by Manufacturer11/26/2018
Initial Report FDA Received Date09/07/2018
Supplement Report FDA Received Date12/20/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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