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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INCORPORATED COOK; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
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COOK INCORPORATED COOK; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number G23259
Device Problems Defective Component (2292); Device Dislodged or Dislocated (2923)
Patient Problem Failure of Implant (1924)
Event Date 09/09/2022
Event Type  malfunction  
Event Description
Patients ij tlc removed/out inadvertently.A red piece was still sutured to patient, but line came out.Patient was not moving head back and forth.Always leans to right side where line was.Md saw it as well and questioned it.Manufacturer response for catheter, ij tlc - short 15 cm tlcs (per site reporter) kit was discarded, tlc was saved.[redacted date] - kit identified that defective part is packaged in.Cook rep identified; email sent reporting this incident and requesting rma/mailer.[redacted date] - rep informed cook customer relations of this incident.[redacted date] - cook email received requesting clinical information.
 
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Brand Name
COOK
Type of Device
CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
COOK INCORPORATED
750 daniels way
bloomington IN 47404
MDR Report Key15601917
MDR Text Key301736102
Report Number15601917
Device Sequence Number1
Product Code FOZ
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 09/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/13/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberG23259
Device Catalogue NumberC-UTLMY-701J-CCT-A-RD
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/21/2022
Event Location Hospital
Date Report to Manufacturer10/13/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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