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	G58905
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2a: additional common name: dre dilator, vessel, for percutaneous catheterization.D2b: additional product code: dre.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 or Problem Description
It was reported that a catheter hub from a 'cook cvc triple lumen power-injectable central venous catheter tray' was cracked and leaking.The patient's central line was noted to be leaking at the hub of the blue port.Upon closer observation by the staff, the hub was noted to be cracked.When the catheter was flushed, "it would shoot water out of the crack in the hub" the catheter was removed after discussing with the provider.At this time, no adverse effects or additional procedures for the patient were reported due to this occurrence.Additional information regarding the event and patient outcome has been requested but is currently unavailable.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged or unavailable.Investigation ¿ evaluation it was reported that the blue port of a cook cvc triple lumen power-injectable central venous catheter tray was cracked and leaking.The line placed on (b)(6) 2024.Later, when the catheter was flushed, "it would shoot water out of the crack in the hub¿ the catheter was removed on (b)(6) 2024 after discussing with the provider.It is unknown if the device was replaced.No adverse effects or additional procedures for the patient were reported due to this occurrence.Reviews of the documentation, including the complaint history, quality control procedures, device history record (dhr), and instructions for use (ifu), were conducted during the investigation.The complaint device was not returned for evaluation; therefore, a physical examination could not be conducted.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 complaint history search identified one additional complaint on the reported lot for a different failure mode.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 the field.Product labeling review: the product ifu, [c_t_cteulm_rev1] ¿cook unimpregnated central venous catheter with power injection,¿ provides the following information to the user related to the reported failure mode: warnings ¿the safe and effective use of central venous catheters with power injector pressures (safety cut-off) set above 325 psi has not been established for 4.0 and 5.0 french and 7.0, 8.0 ,9.0, and 10.0 french, respectively.Do not power inject if maximum injection rate cannot be verified to be limit of 3ml/sec for 4.0 and 5.0 french and 10 ml/sec for 7.0.8.0.9.0.And 10.0 french.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 250 psi and maximum flow rate of 3 ml/sec for 4.0 and 5.0 french and 325 psi and that the maximum flow of 10ml/sec for 7.0, 8.0, 9.0, and 10.0 french.Do not exceed the maximum flow rate of 3ml/sec for 4.0 and 5.0 french and 10ml/sec for 7.0, 8.0, 9.0, and 10.0 french.Exceeding the maximum flow rate of 10ml/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 ¿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.¿ instructions for use power injection procedure ¿6.Conduct study using the power injector, making sure not to exceed the maximum flow rate of 3ml/sec or pressure limit safety cut-off of 250 psi for 4.0 and 5.0 french catheters or the maximum flow rate of 10ml/sec or pressure limit safety cut-off of 325 psi for 7.0, 8.0, 9.0, and 10.0 french catheters.¿ how supplied, ¿upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the information provided, no product returned, and the results of our investigation, it was concluded that a component failure unrelated to manufacturing or design deficiencies contributed to the reported event.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the risk assessment no further action is required.A capa was previously opened to further investigate this failure mode.Investigation 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 by introducing additional forces to the hub.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 or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: COOK CVC TRIPLE LUMEN POWER-INJECTABLE CENTRAL VENOUS CATHETER TRAY
• 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: 20495131
• Report Number: 1820334-2024-01383
• Device Sequence Number: 14341026
• Product Code: FOZ
• UDI-Device Identifier: 00827002589056
• UDI-Public: (01)00827002589056(17)260430(10)15623188
• Combination Product (Y/N): Y
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2026
• Device Model Number: G58905
• Device Catalogue Number: UTLMY-7.0-32-1-20-IHI
• Device Lot Number: 15623188
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/09/2024
• Supplement Date Received by Manufacturer: 09/04/2025
• Initial Report FDA Received Date: 10/21/2024
• Supplement Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2023
• 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
• Patient Sex: Unknown