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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC REDO DOUBLE LUMEN TPN CATHETER SET

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COOK INC REDO DOUBLE LUMEN TPN CATHETER SET Back to Search Results
Model Number G07935
Device Problem Material Separation (1562)
Patient Problem No Code Available (3191)
Event Date 11/23/2020
Event Type  Injury  
Manufacturer Narrative
Date of birth: born in 2019. Common device name: not available as this device is not sold in the us, but it is considered to be clinically similar to a device that is, thus prompting this report. Occupation: unknown. Pma/510(k): not available as this device is not sold in the us, but it is considered to be clinically similar to a device that is, thus prompting this report. (b)(4). This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
 
Event Description
It was reported that a redo double lumen tpn catheter burst during injection. The catheter was placed into the right thorax of the pediatric patient on (b)(6) 2020. On (b)(6) 2020, the catheter burst during an unknown injection given in the pediatrics department. The patient was put under anesthesia in order to have the device removed and replaced. This led to an interruption in therapy for the patient. No additional adverse effects to the patient have been reported.
 
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Brand NameREDO DOUBLE LUMEN TPN CATHETER SET
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer (Section G)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
jason crouch
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key10941399
MDR Text Key219383374
Report Number1820334-2020-02229
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 04/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/04/2021
Device Model NumberG07935
Device Catalogue NumberC-TPNS-5.0D-65-12-REDO
Device Lot Number8439317
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/11/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/12/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/04/2018
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: 12/03/2020 Patient Sequence Number: 1
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