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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INCORPORATED COOK; CATHETER, PERCUTANEOUS
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COOK INCORPORATED COOK; CATHETER, PERCUTANEOUS Back to Search Results
Model Number G26930
Device Problem Device Damaged Prior to Use (2284)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/24/2022
Event Type  malfunction  
Event Description
Cardiology attending prepping to place central line on an inpatient.Opened kit and found the needle exposed and popping through the sterile fields.Risk for needle stick injury.Kit secured and left for pcicu management for further work up.Manufacturer response for central venous tray, 4 fr 5 cm double lumen central venous tray (per site reporter) emailed cook rep; cook# (b)(4) assigned to investigation; mailer label received; cook response email received - rma/mailer in route; sample shipped (b)(6) using the emailed shipping label.
 
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Brand Name
COOK
Type of Device
CATHETER, PERCUTANEOUS
Manufacturer (Section D)
COOK INCORPORATED
750 daniels way
bloomington IN 47404
MDR Report Key14512287
MDR Text Key292714700
Report Number14512287
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 05/06/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/26/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberG26930
Device Catalogue NumberC-UDLMY-401J-PED-CCT
Device Lot Number14485788
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/04/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/06/2022
Event Location Hospital
Date Report to Manufacturer05/26/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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