MAUDE Adverse Event Report: COOK INC FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problems Obstruction of Flow (2423); Material Twisted/Bent (2981)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: the date of the event is currently unknown, however was reported to have happened within the last two weeks. Device name: cook spectrum minocycline / rifampin impregnated triple lumen central venous catheter set common name, g4: product is not for sale in the united states. However, information was chosen for a same/similar device that is sold in the united states. Customer (person): postal code - (b)(6). 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 kinking between the insertion site and the hub of a cook spectrum minocycline / rifampin impregnated triple lumen central venous catheter caused blockage of one of the lumens. Twenty centimeters of the central venous catheter was inserted into the internal jugular vein (ij) of the patient. The insertion was described as being located in the lower part of the neck, where the neck meets the shoulder. A few centimeters of catheter remains outside of the body, as the catheter is angled so the extension lumens face downwards. A clear dressing tape is put over the whole area to keep it in place. These insertions are predominantly done in "recovery" or in "the theatre". If a patient is too sick to travel, then the insertion will take place in the ward. Once the patient is returned to the ward, nursing staff noticed a kink in the catheter where it has been angled between the insertion site and the hub. It is believed that patient head movement caused the kink. At times, these kinks have lead to the blockage of the lumens. Attempts to manipulate and unkink the catheter are made, and if this is not possible, the remaining unblocked lumens are used. If the patient requires the use of all three lumens for treatment, the device is removed and replaced. The hospital's policy is to also use two anchor points so they always use the msw at the insertion site and suture at the winged hub at the end of the catheter. Cvc placements are completed by experienced inserters. This has occurred with six separate patient insertions at this facility. This report references one patient who did not require cvc replacement. Other related instances are referenced in reports with patient identifiers: 324715, 324716, 324717, 324718 and 324719. Additional information regarding device details has been requested, but is currently unavailable.

• 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: 11505869
• MDR Text Key: 243355997
• Report Number: 1820334-2021-00955
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): Y
• PMA/PMN Number: K081113
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 01/14/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: C-UTLM-701J-RSC-ABRM-HC-RD-AU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/07/2022
• 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