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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK, INC. CXI SUPPORT CATHETER; CATHETER, CONTINUOUS FLUSH

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COOK, INC. CXI SUPPORT CATHETER; CATHETER, CONTINUOUS FLUSH Back to Search Results
Catalog Number G52544
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Information (3190)
Event Date 08/10/2017
Event Type  malfunction  
Event Description
A cxi support catheter 150cm in length got stuck going over an 0.035" amplatz wire, so stuck, the luer-lock hub from one end of the catheter broke off trying to remove it over-the-wire.
 
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Brand Name
CXI SUPPORT CATHETER
Type of Device
CATHETER, CONTINUOUS FLUSH
Manufacturer (Section D)
COOK, INC.
750 daniels way
bloomington IN 47404
MDR Report Key6841403
MDR Text Key84640584
Report Number6841403
Device Sequence Number1
Product Code KRA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 08/17/2017
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 Physician
Device Catalogue NumberG52544
Device Lot Number7272183
Other Device ID NumberCXI-4.0-35-150-P-NS-0
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/17/2017
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer08/17/2017
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/05/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
A CXI SUPPORT CATHETER 150CM IN LENGTH GOT STUCK G
Patient Age68 YR
Patient Weight121
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