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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC TRIPLE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER SET DQY CATHETER, PERCUTANEOUS

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COOK INC TRIPLE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER SET DQY CATHETER, PERCUTANEOUS Back to Search Results
Model Number N/A
Device Problem Crack (1135)
Patient Problems Hemorrhage/Bleeding (1888); Discomfort (2330); No Code Available (3191)
Event Date 06/08/2020
Event Type  Injury  
Manufacturer Narrative
(b)(6). Occupation: unknown. Pma/ 510(k) #: pre-amendment. The patient required additional medication and additional procedure to remove and replace the device to preclude permanent impairment/death. Additionally, the patient experienced a delay in receiving treatment. A follow-up report will be submitted should additional relevant information become available.
 
Event Description
It was reported that a crack was discovered by a nurse on one of the catheter lumens of a triple lumen polyurethane central venous catheter set approximately 12 hours after insertion over the patient's right femoral vein, allowing for the backflow of blood. Consequently, there was a delay in medication infusion as well as discomfort experienced by the patient. Ultimately, due to inadequate lumens to infuse medication, the device was removed and replaced into the patient's right internal jugular. Following the discovery of the crack, the patient required medicine to stop "continuous bleeding". It was also reported that the patient was unable to move. Additional information regarding the device has been requested but is currently unavailable.
 
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Brand NameTRIPLE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER SET
Type of DeviceDQY CATHETER, PERCUTANEOUS
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer (Section G)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
jennifer canada
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key10152996
MDR Text Key195124882
Report Number1820334-2020-01131
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeMY
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/16/2021
Device Model NumberN/A
Device Catalogue NumberC-UTLM-501J
Device Lot Number8776962
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/09/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/29/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/16/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/15/2020 Patient Sequence Number: 1
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