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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MEXICO DUET EXTERNAL DRAINAGE AND MONITORING SYSTEM; DEVICE, MONITORING, INTRACRANIAL PRESSURE
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MEDTRONIC MEXICO DUET EXTERNAL DRAINAGE AND MONITORING SYSTEM; DEVICE, MONITORING, INTRACRANIAL PRESSURE Back to Search Results
Model Number 46914
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 12/02/2019
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
It was reported that the external drainage and monitoring system was noted to have a large crack on either side of one of the stopcocks.The stopcock itself should be affixed to the system but was broken off.It was noted that there was no apparent harm.
 
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Brand Name
DUET EXTERNAL DRAINAGE AND MONITORING SYSTEM
Common Device Name
DEVICE, MONITORING, INTRACRANIAL PRESSURE
Manufacturer (Section D)
MEDTRONIC MEXICO
av. paseo del cucapah #10510
tijuana,bc 22570
MX  22570
MDR Report Key9507342
Report Number9612164-2019-05285
Device Sequence Number16999693
Product Code GWM
UDI-Device Identifier00613994445377
UDI-Public00613994445377
Combination Product (Y/N)N
Initial Reporter CountryCA
PMA/510(K) Number
K983799
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/20/2019
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 Date05/27/2022
Device Model Number46914
Device Catalogue Number46914
Device Lot Number217759461
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/17/2019
Initial Report FDA Received Date12/20/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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