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

Model Number	G47829
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Correction: d4-model#, h6-annex a.Investigation ¿ evaluation: (b)(6) 2024, it was reported that the blue hub in a cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter set was leaking after placement in the neck of a 39-year-old male patient.The leakage was discovered immediately after the procedure during the injections.The catheter was replaced, and there were no adverse effects to the patient due to this occurrence.A video provided by the customer showed a crack in the catheter hub.Reviews of the documentation, including the complaint history, device history record, quality control procedures, and instructions for use of the device, 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 the failure mode prior to distribution.A review of the device history record (dhr) for the device lot found no relevant recorded nonconformances that could have contributed to the reported failure mode.It should be noted that there were two other complaints associated with the final product lot number.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.¿ evidence gathered upon review of dmr, product labeling, and dhr, does not indicate the device was manufactured out of specification.There is no evidence of nonconforming material in house or in the field.Based on the information provided, no returned product 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 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.Per the risk assessment no further action is required.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.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.
Event or Problem Description
In additional information it was reported that the leak was noted immediately after the procedure during injection.The patient required replacement of the cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter.
Additional 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 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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.D1 - device name: cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter set.E1 - customer (person): (b)(6).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 or Problem Description
It was reported that leakage was found coming from the blue port of the cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter after placement in the neck of a 39-year-old male patient.The patient did not experience any adverse effects due to this occurrence.A video provided by the customer showed a crack in the catheter hub.Additional information regarding event details has been requested but is currently unavailable.

• 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: 19121298
• Report Number: 1820334-2024-00535
• Device Sequence Number: 12702701
• Product Code: FOZ
• UDI-Device Identifier: 00827002478299
• UDI-Public: (01)00827002478299(17)251128(10)15400966
• Combination Product (Y/N): Y
• 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,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/22/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/28/2025
• Device Model Number: G47829
• Device Catalogue Number: C-UTLM-701J-RSC-ABRM-HC-RD
• Device Lot Number: 15400966
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/09/2024
• Supplement Date Received by Manufacturer: 04/17/2024; 07/29/2024
• Initial Report FDA Received Date: 04/16/2024
• Supplement Report FDA Received Date: 05/06/2024; 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 39 YR
• Patient Sex: Male
• Patient Weight: 70 KG