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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN MONOJECT 8 QT CT CONT - RED; CONTAINER, SHARPS
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COVIDIEN MONOJECT 8 QT CT CONT - RED; CONTAINER, SHARPS Back to Search Results
Model Number 8881676285
Medical Device Problem Code Difficult to Open or Close (2921)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
 
Event or Problem Description
The customer reported that the tabs are breaking.Additional information received from the initial reporter stated that tabs are breaking means the lid would not be able to lock in place.There was no reported injury.
 
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Brand Name
MONOJECT 8 QT CT CONT - RED
Common Device Name
CONTAINER, SHARPS
Manufacturer (Section D)
COVIDIEN
15 hampshire street
mansfield MA 02048
MDR Report Key10891779
Report Number1282497-2020-09656
Device Sequence Number3254460
Product Code MMK
UDI-Device Identifier10884521018860
UDI-Public10884521018860
Combination Product (Y/N)N
Initial Reporter StatePA
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 11/23/2020
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 No Information
Device Model Number8881676285
Device Catalogue Number8881676285
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 11/06/2020
Initial Report FDA Received Date11/24/2020
Patient Sequence Number1
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