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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INCORPORATED COOK INTRODUCER, CATHETER

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COOK INCORPORATED COOK INTRODUCER, CATHETER Back to Search Results
Model Number G57485
Device Problems Material Frayed (1262); Defective Device (2588); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/15/2021
Event Type  malfunction  
Event Description
The proximal and distal portions of the catheter in the liver biopsy kit were defective. The catheter was removed without incident or harm. Catheter frayed at the bottom. The luer lock part at the top fell off.
 
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Brand NameCOOK
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
COOK INCORPORATED
750 daniels way
bloomington IN 47404
MDR Report Key12266229
MDR Text Key264706217
Report Number12266229
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 07/26/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG57485
Device Catalogue NumberLABS-100-J-01
Device Lot Number13589436
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/26/2021
Event Location Hospital
Date Report to Manufacturer08/03/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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