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

Model Number N/A

Device Problem Obstruction of Flow (2423)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/13/2023

Event Type  malfunction  

Manufacturer Narrative

Device name: cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter tray.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

It was reported that two of the three lumens of a cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter tray were found to be occluded at an unknown time after placement into the right internal jugular vein of a hospitalized 83-year-old male patient.Both of the non-red ports were unable to flush or draw blood following placement.It was noted that the line was not flushed prior to placement.As a result, the device was removed from the patient and replaced with a like-device.Additional information regarding event details has been requested but is currently unavailable.

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.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 25jan2023.The occlusion was noticed immediately after insertion.The device was removed and replaced in the same procedure before the sterile field was taken down.An additional "stick" was required.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged or unavailable.Correction: c.Suspect product(s) investigation ¿ evaluation medline industries-c47 (united states) informed cook that on 13jan2023, the cvc in a cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter tray (rpn: c-utlmy-701j-abrm-custom-0001, lot: 14878394) was unable to be flushed.Before insertion the central line was not flushed.After the device was inserted into the right internal jugular, both non red ports wouldn¿t flush or draw blood.The catheter was removed and replaced with a new one in the same procedure.It was reported that there are no adverse effects to the patient due to this occurrence.Reviews of the documentation, including the complaint history, device history record, instructions for use (ifu), manufacturing instructions and quality control procedures, as well as a visual inspection and functional test of the returned device, were conducted during the investigation.One used device was returned for evaluation.During table-top testing, all ports were able to be flushed.There was slight resistance noted in the white and blue ports, with blood/biological matter exiting from the lumens.Additionally, 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 prior to distribution.A review of the device history record (dhr) for lot 14878394 and related subassemblies found no nonconformances that could have contributed to the reported failure.It should be noted that no other complaints have been associated with the final product lot number.Cook also reviewed product labeling.The 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 ¿failure to ensure patency of the catheter prior to power injection studies may result in catheter failure.¿ 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.¿ suggested catheter maintenance ¿to prevent clotting or possibility of air embolus, the double lumen¿s #2 lumen, the triple-lumen¿s #2 and #3 lumens, and the five-lumen¿s #2, #3, #4 and #5 lumens should be filled with saline solution or heparinized saline solution (100 units of heparin per ml of saline is usually adequate), depending on institutional protocol, prior to catheter introduction.After catheter is placed and prior to use, tip position and lumen patency should be confirmed by free aspiration of venous blood.If blood is not freely aspirated, physician should immediately reevaluate catheter tip position.Failure to ensure patency of the catheter prior to power injection studies may result in catheter failure.¿ instructions for use ¿2.Prepare the catheter for insertion by flushing each of the lumens and clamping or attaching the injection caps to the appropriate extensions.Leave the distal extension uncapped for wire guide passage.¿ evidence gathered from a review of the dmr, product labeling, dhr, and device failure analysis, 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, examination of the returned product, and the results of our investigation, it was concluded that a failure to follow instructions could be attributed to the incident.The customer informed cook that they had not flushed the catheter before insertion.It was found during evaluation of the returned device that lumens 2 and 3 were occluded with biological matter.The ifu required the user to flush the device and fill lumens 2 and 3 with heparinized saline solution before insertion.The appropriate personnel have been notified.Per the risk assessment no further action is required.We 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 Description

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

• Brand Name: COOK SPECTRUM
• 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: 16233338
• MDR Text Key: 308005186
• Report Number: 1820334-2023-00056
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00827002564220
• UDI-Public: (01)00827002564220(17)240801(10)14878394
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K081113
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 05/22/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2024
• Device Model Number: N/A
• Device Catalogue Number: C-UTLMY-701J-ABRM-CUSTOM-0001
• Device Lot Number: 14878394
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2023
• Initial Date FDA Received: 01/24/2023
• Supplement Dates Manufacturer Received: 01/25/2023; 04/27/2023
• Supplement Dates FDA Received: 01/27/2023; 05/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male