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

Model Number	G47825
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the catheter from a cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter set was leaking.Upon flushing the red lumen with saline, the nurse noticed a significant leak from the insertion site.To verify the leak was from the catheter and not the patient tissues, a small amount of propofol was injected into the red lumen.The white colored propofol liquid was then noted to leak from the insertion site.The catheter was removed and replaced immediately.After removal, the device was inspected by the customer.Upon flushing the white and blue lumens, the catheter was noted to function normally with no leaks.When the red lumen was flushed, leaking was noted from an approximate 1 cm long "hairline" crack at the most proximal portion of the catheter ("which would have been right about 5 mm into the patient's skin").The site reported that the red lumen had been utilized for infusions of antibiotics, a magnesium infusion, and balanced electrolyte solution.No other adverse effects were reported for this incident.Additional information regarding the event and patient outcome has been requested but is currently unavailable.
Additional Manufacturer Narrative
D1 - brand name: cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter set.E3 - occupation: senior clinical risk advisor, medical device safety, pq&s h3 - device evaluated by mfg?: device evaluation anticipated but has not begun.Awaiting device return.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 or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
H3 - device evaluated by mfg? device not returned to manufacturer correction: d9, h3.Investigation ¿ evaluation.It was reported that the catheter from a cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter set leaked.Upon flushing the red lumen with saline, the nurse noticed a significant leak from the insertion site.To verify the leak was from the catheter and not the patient tissues, a small amount of propofol was injected into the red lumen.The white colored propofol liquid was then noted to leak from the insertion site.The catheter was removed and replaced immediately.After removal, the device was inspected by the customer.Upon flushing the white and blue lumens, the catheter was noted to function normally with no leaks.When the red lumen was flushed, leaking was noted from an approximate 1 cm long "hairline" crack at the most proximal portion of the catheter.No other adverse effects were reported for this incident.The site noted the red lumen had been utilized for infusions of antibiotics, a magnesium infusion, and balanced electrolyte solution.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), and quality control were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the dhr for the reported complaint device lot and related subassembly lots revealed no recorded non-conformances relevant to the failure mode.A database search did not identify any other events associated with the reported device lot.Based on the available information, cook has concluded that the device was manufactured to specification and that there is no evidence suggesting nonconforming product exists either in house or in field.Cook also reviewed product labeling.The ifu supplied with the device states the following in consideration of the reported failure mode: warnings ¿ ¿ 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/health 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 10ml/sec.¿ do not exceed the maximum flow rate of 10ml/sec.Exceeding the maximum flow rate of 10ml/sec may result in catheter failure and/or catheter tip displacement.¿ precautions ¿¿ if lumen flow is impeded, do not force injection or withdrawal of fluids.Failure to ensure patency of the catheter prior to power injection studies may result in catheter failure.Notify attending physician immediately.¿ suggested catheter maintenance "to prevent clotting or possibility of air embolus, the double lumens #2 lumen, the triple lumens #2 and #3 lumens, and the five lumens #2, #3 #4, and #5 lumens should be filled with saline solution or heparinized saline solution, depending on institutional protocol, prior to catheter introduction.Any unused lumens should be maintained with continuous saline or heparinized saline drip or locked with heparinized saline solution.Before using any lumen already locked with heparin, lumen should be flushed with twice the indicated lumen volume using normal saline.Lumens should be flushed with normal saline between administrations of different infusates.After use, lumen should again be flushed with twice the indicated lumen volume using normal saline before reestablishing heparin lock." how supplied ¿upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the available information, no product returned, and the results of the investigation, cook has concluded that component failure unrelated to manufacturing or design deficiencies contributed to the event.It is possible that the lumen was occluded and over pressurization of the catheter caused the fracture.However, without additional information and device return, cook cannot confirm this possibility.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the risk assessment no further action is required.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.

• Common Device Name: 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: 22702482
• Report Number: 1820334-2025-00927
• Device Sequence Number: 18395010
• Product Code: FOZ
• UDI-Device Identifier: 00827002478251
• UDI-Public: (01)00827002478251(17)270521(10)16169233
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• PMA/510(K) Number: K081113
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2025

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
• Operator of Device: Health Professional
• Device Model Number: G47825
• Device Catalogue Number: C-UTLM-701J-ABRM-HC-RD
• Device Lot Number: 16169233
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Fifteen-Day
• Initial Date Received by Manufacturer: 07/23/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 08/04/2025
• Supplement Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/22/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown