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

Model Number	N/A
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A patient had a cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter inserted in the left side of their neck.A leak in the blue hub was discovered by the physician.The device was removed.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 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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.Additional information: b5.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
Additional information was provided on 28jul2023.The leakage occurred at the junction of the blue hub and the extension tubing.After catheter placement, the maintenance protocol for the device, which is completed by the nurses, is to flush the lumens using normal saline.The catheter was removed and replaced.Based on previous information provided regarding patient outcome (no additional procedures required), it is reasonable to presume that this occurred during the same procedure.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Correction: h6 (medical device problem code - annex a) investigation ¿ evaluation a patient had a cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter inserted in the left side of their neck.A leak in the blue hub was discovered by the physician.The leakage occurred at the junction of the blue hub and the extension tubing.After catheter placement, the maintenance protocol for the device, which is completed by the nurses, is to flush the lumens using normal saline.The catheter was removed and replaced.Based on information provided regarding patient outcome (no additional procedures required), it is reasonable to presume that this occurred during the same procedure.It was reported that the patient did not experience any adverse effects due to this occurrence.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), and quality control procedures for the device, 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.In response to this incident, cook completed a review of the product device master record (dmr) and concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Cook also reviewed the device history record (dhr).The dhr for the reported lot, and its sub assembly and raw material lots, records no relevant non-conformances.A database search for complaints on the reported lot found no additional complaints reported from the field.Cook concluded that no non-conforming product from this lot exists in house or in the field.The information provided upon review of device master record, product labeling, and device history record does not indicate the device was manufactured out of 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, no returned device, and the results of the investigation, it was determined the cause of this event is design related.It is likely that the hub was cracked, as there have been similar complaints on the same rpn where the cracked hubs lead to leaking.A capa was previously open to address the issue of cracked hubs in this product line.The capa concluded that the main cause of failure was design-related.A project was initiated to further investigate this issue.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, 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.

• 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: 17400379
• Report Number: 1820334-2023-00966
• Device Sequence Number: 20763780
• Product Code: FOZ
• UDI-Device Identifier: 00827002478299
• UDI-Public: (01)00827002478299(17)250725(10)14957862
• 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,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/25/2024

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: 07/25/2025
• Device Model Number: N/A
• Device Catalogue Number: C-UTLM-701J-RSC-ABRM-HC-RD
• Device Lot Number: 14957862
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/24/2023
• Supplement Date Received by Manufacturer: 07/28/2023; 01/09/2024
• Initial Report FDA Received Date: 07/26/2023
• Supplement Report FDA Received Date: 08/02/2023; 01/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2022
• 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: Female