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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INCORPORATED DAWSON MUELLER; CATHETER, NEPHROSTOMY
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COOK INCORPORATED DAWSON MUELLER; CATHETER, NEPHROSTOMY Back to Search Results
Model Number G51595
Device Problem Failure to Advance (2524)
Patient Problem Insufficient Information (4580)
Event Date 01/10/2023
Event Type  malfunction  
Event Description
Doctor was placing a drain in a patient.A 6.3 fr.Dawson-mueller multipurpose drainage catheter was opened and loaded over a wire.The catheter would not advance or curl into the area of interest, it just buckled.A second 6.3 fr.Drainage catheter was opened, but it did the same exact thing.Neither drain was used because they would not properly advance or curl in the affected area.Manufacturer response for catheter, nephrostomy, dawson mueller (per site reporter).Cook representative replaced device.No sample was requested.
 
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Brand Name
DAWSON MUELLER
Type of Device
CATHETER, NEPHROSTOMY
Manufacturer (Section D)
COOK INCORPORATED
750 daniels way
bloomington IN 47404
MDR Report Key16183586
MDR Text Key307478204
Report Number16183586
Device Sequence Number1
Product Code LJE
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/12/2023
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
Device Operator Health Professional
Device Model NumberG51595
Device Catalogue NumberULT6.3-35-25-P-5S-CLDM-HC
Device Lot Number14807363
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/12/2023
Event Location Hospital
Date Report to Manufacturer01/17/2023
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/17/2023
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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