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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN P400 PREM U/M 14FR TMP SNS CSD; DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE
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COVIDIEN P400 PREM U/M 14FR TMP SNS CSD; DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE Back to Search Results
Model Number P4P14TSD
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 11/07/2020
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 the 14 fr temp sensing foley came disconnected at the taped hub when staff were not in the room.The provider was notified and the device was replaced.There was no harm to the patient.
 
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Brand Name
P400 PREM U/M 14FR TMP SNS CSD
Common Device Name
DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE
Manufacturer (Section D)
COVIDIEN
calle 9 sur no. 125 cuidad ind
tijuana 22500
MX  22500
MDR Report Key10828680
Report Number9612030-2020-02690
Device Sequence Number4178400
Product Code FFG
UDI-Device Identifier10884521066953
UDI-Public10884521066953
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,user f
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 11/12/2020
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 NumberP4P14TSD
Device Catalogue NumberP4P14TSD
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 11/09/2020
Initial Report FDA Received Date11/12/2020
Patient Sequence Number1
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