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

Model Number N/A

Device Problem Obstruction of Flow (2423)

Patient Problems Obstruction/Occlusion (2422); Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported to cook that there have been several occasions where the staff has noticed occlusion of the cook spectrum antibiotic impregnated central venous catheters when they are used in pediatric patients.Additional information has been requested but has not been provided at the time of this report.

Manufacturer Narrative

Common device name.: code based on most commonly sold cvc device in australia (c-uqlm-1001j-rsc-abrm-hc-rd).Initial reporter name and address: unknown customer, customer contact e-mail: (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 Description

Additional information was provided on 31jul2022.The pediatric patient had an infusion of propofol running in the cook spectrum antibiotic impregnated central venous catheter.Ancillary devices were being used to include an infusion pump, extension line, and a needle free connector/valve.The infusion was running at a rate of more than 1ml/hr through the lumens.When possible, a turbo flush through each lumen was performed, usually each shift (8-12hrs).The device was discovered to have been occluded.Additional information has been requested regarding the event but has not been provided.No adverse effects to the patient have been reported.

Manufacturer Narrative

A4 : weight: 3.5 kilograms.E1: phone: (b)(6).E3: occupation: clinical nurse, pccu.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.

Manufacturer Narrative

Investigation ¿ evaluation: (b)(6) hospital notified cook on 20jun2022 regarding an issue with a cook spectrum antibiotic impregnated set (rpn and lot unknown).The cvc¿s lumen was occluded while infusing propofol at 1 ml/hour with another manufacturer's syringe driver.When possible, they turbo flushed through each lumen, usually each shift (8-12hrs).The device occluded despite a continuous infusion running.The patient reportedly experienced no adverse effects because of this incident.A review of the complaint history, instructions for use (ifu), and quality control procedures 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.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.Because the customer did not provide the lot number for the complaint device, the device history record (dhr) could not be reviewed.Cook reviewed the sales history for this customer and was unable to identify the complaint lot.The information provided upon review of device master 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_ulmabrmau_rev0] ¿spectrum central venous catheters,¿ provides the following information to the user related to the reported failure mode: warnings: ¿every effort must be made to ascertain proper tip position in order to prevent erosion or perforation of central venous system.Tip position should be verified by x-ray and monitored on a routine basis.Periodic lateral view x-ray is suggested to assess tip location in relation to vessel wall.Tip position should appear to be parallel to vessel wall.Precautions: ¿patient movement can cause catheter tip displacement.Use should be limited to controlled hospital situations.If lumen flow is impeded, do not force injection or withdrawal of fluids.¿ product recommendations: suggested catheter maintenance: ¿to prevent clotting or possibility of air embolus, the double-lumen¿s #2 lumen, and the triple lumen¿s #2 and #3 lumens should be filled with saline solution or heparinized saline solution (100 units of heparin per cc of saline is usually adequate), 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.Heparin-locked lumens should be reestablished at least every 8 hours.Before using any lumens 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.¿ instructions for use: ¿2.Prepare the catheter for insertion by flushing each or the lumens and clamping or attaching the injection caps to the appropriate extensions.Leave the distal extension uncapped for wire guide passage.¿ based on the information provided, no return device, and the results of the investigation, cook has concluded that component failure unrelated to manufacturing or design deficiencies contributed to the event.It was stated that the catheters lumens had continuous infusions, but it is still possible that biomatter accumulated and occluded the lines, though this can not be confirmed.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 Description

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

• Brand Name: UNKNOWN
• 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: 14892531
• MDR Text Key: 303714363
• Report Number: 1820334-2022-01148
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 10/10/2022

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/20/2022
• Initial Date FDA Received: 07/01/2022
• Supplement Dates Manufacturer Received: 07/31/2022; 09/13/2022
• Supplement Dates FDA Received: 08/02/2022; 10/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 50 ML BD PLASTIPAK SYRINGE.; BRAUN 180 CM EXTENSION LINE.; FRESENIUS AGILIA SYRINGE DRIVER.; ICU MEDICAL NANO CLAVE CONNECTOR.
• Patient Age: 4 WK
• Patient Sex: Male
• Patient Weight: 4 KG