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

Model Number N/A

Device Problems Crack (1135); Fluid/Blood Leak (1250); Fracture (1260); Fitting Problem (2183)

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

Event Date 10/10/2023

Event Type  Injury  

Manufacturer Narrative

D1 - device name: cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter set.E3 - occupation: clinical nurse manager.H6 - annex g: g0402301 - catheter hub.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

It was reported that the hub of a cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter leaked while flushing.The device was placed on an unknown date in the left atrium for blood monitoring and medication administration.The patient was receiving epinephrine and was not mobile.No fitting was connected to the device at the time of failure.During flushing, leaking was noted from the distal and proximal hubs.The lines were clamped.The device was removed and replaced.The device was returned to the manufacturer on 06nov2023.During the preliminary device failure analysis, the red and white hubs of the device were found to be cracked and leaking.

Manufacturer Narrative

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.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

In additional information received on 05dec2023, it was reported that the device was placed on (b)(6) 2023, and the failure occurred on (b)(6) 2023.The failed lumens were clamped, and the functional lumens were continued to be used due to patient acuity.The line was removed and replaced the next day on (b)(6) 2023.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Investigation ¿ evaluation: on 27oct2023, cook became aware of an event on 10oct2023.The hubs of a cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter set leaked while flushing.The device was placed on (b)(6) 2023 in the left atrium for blood monitoring and medication administration.The patient was receiving epinephrine and was not mobile.No fitting was connected to the device at the time of failure.During flushing, leaking was noted from the distal and proximal hubs on (b)(6) 2023.The failed lumens were clamped, and the functional lumens were continued to be used due to patient acuity.The line was removed and replaced the next day on (b)(6) 2023.Reviews of documentation including the complaint history, quality control procedures, and instructions for use (ifu), as well as a visual inspection and functional test of the returned device, were conducted during the investigation.One used device was returned to cook for evaluation.Table top testing found leakage in both the red and white hubs.Upon visual inspection, cracks were noted on both the red and white ports.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the device history record (dhr) was unable to be completed due to a lack of lot information.An expanded sales search to the customer was unable to identify the complaint lot.Based on this information, the device was manufactured to specification.There is no evidence of nonconforming material in house or in the field.Cook also reviewed product labeling.The product ifu, [c_t_ctulmabrm_rev7] "cook spectrum central venous catheter minocycline/rifampin antibiotic impregnated power injectable," provides the following information to the user related to the reported failure mode: warnings: "the safe and effective use or central venous catheters with power injector pressures (safety but-off) set above 325 psi has not been established.Do not power inject if maximum injection rate cannot be verified to meet limit of 10ml/sec.To safely use catheters with a power injector, the technician/heath care professional must verify prior to use that the maximum safety cut-off pressure limit is set at or below 325 psi and that the maximum flow rate is at or below 10 ml/sec.Do not exceed the maximum flow rate of 10 ml/sec.Exceeding the maximum flow rate of 10 ml/sec may result in catheter failure and/or catheter tip displacement.Power injector machine pressure limiting (safety cut-off) settings may not prevent over-pressurization of an occluded catheter.Precautions: "catheter should not be used for long-term indwelling applications." based on the information provided, inspection of the returned device, and the results of the investigation, cook has concluded that the main cause of failure is design-related.A capa was previously opened, and a project is currently open to further investigate this failure mode.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the risk assessment no further action is required.Appropriate measures have been taken to address this failure mode.A project is in place to further investigate this failure mode.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, that a death or serious injury occurred, nor 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

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Correction: h6 - annex a, annex g, annex d, investigation conclusion (see below).Based on the information provided, inspection of the returned device, and the results of the investigation, cook determined, among other variables, that over-engagement of external components onto the hub may contribute to cvc hub cracking.The use of hemostats or lubrication, such as fluids remaining on the hub, during application of external components may further contribute to over-engagement, introducing additional forces to the hub.The investigation concluded that the main cause of failure was a component failure without a design or manufacturing deficiency.The reported failure is captured in the risk documentation and is occurring within the acceptable range.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the risk assessment no further action is required.Appropriate measures have been taken to address this failure mode.A capa was previously opened to further investigate this failure mode.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, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• 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: 18084573
• MDR Text Key: 327536430
• Report Number: 1820334-2023-01508
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K081113
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-UTLM-701J-RSC-ABRM-HC-RD
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2023
• Initial Date FDA Received: 11/07/2023
• Supplement Dates Manufacturer Received: 12/05/2023; 01/11/2024; 02/05/2024
• Supplement Dates FDA Received: 12/08/2023; 01/15/2024; 02/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Required Intervention