MAUDE Adverse Event Report: COOK INC COOK CVC TRIPLE LUMEN POWER-INJECTABLE CENTRAL VENOUS CATHETER TRAY; FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problem Obstruction of Flow (2423)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.B3 - date of event: week of (b)(6) 2023 d2a- additional common name: dre dilator, vessel, for percutaneous catheterization d2b- additional product code: dre d4- rpn: most likely a utlmy-7.0-32-1-20-ihi, as this is the device the facility regularly orders.E3- occupation: value analysis manager g4- pma/510(k) #: k182252 this report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned or that a death or serious injury occurred; nor is it admission that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

As reported, during a one week period of time, the catheters in three cook cvc triple lumen power-injectable central venous catheter trays were occluded.The three catheters were said to require troubleshooting, and cathflo was used to restore patency to the catheters.One catheter took almost two hours to restore patency to the white lumen.As reported, the patients did not experience adverse effects due to this occurrence.It is unknown if the devices had to be replaced.Additional information regarding the event and patient outcome has been requested but is currently unavailable.

• Brand Name: COOK CVC TRIPLE LUMEN POWER-INJECTABLE CENTRAL VENOUS CATHETER TRAY
• Type of Device: FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• 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 Key: 19003104
• MDR Text Key: 339117082
• Report Number: 1820334-2024-00439
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/29/2024

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/20/2024
• Initial Date FDA Received: 03/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1