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

Device Problems Complete Blockage (1094); Obstruction of Flow (2423)

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

Event Date 05/06/2021

Event Type  malfunction  

Manufacturer Narrative

Device name: cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter tray.Device catalog number: c-utlmy-501j-lsc-abrm-hc-ihi-fst.Reporter occupation: clinical product specialist.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

It was reported that the red lumen of a cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter was unable to be flushed prior to patient contact.Prior to inserting the device into the patient, the physician was flushing the lines to verify patency.While doing so, it was noted that one of the hubs was unable to be flushed, specifically the red-colored one.A new device was obtained and successfully inserted without incident.No adverse effects to the patient have been reported.

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 by the customer on 12jul2021.It was reported that the patient was already hospitalized and hospitalization was not prolonged due to the complaint occurrence.The patient did not require any additional procedures or have any adverse effects as the malfunction was discovered prior to patient contact/insertion.

Event Description

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

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.Correction: d9, h3 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

Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Investigation ¿ evaluation good samaritan hospital informed cook of an incident involving a cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter tray (c-utlmy-501j-lsc-abrm-hc-ihi-fst) from an unknown lot.The operator reportedly was unable to flush the red lumen during a central line insertion on 06may2021.The patient had no additional procedures and experienced no adverse effects due to this occurrence.A review of the complaint history, instructions for use (ifu), manufacturing instructions, 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.A device master record (dmr) review was performed, and device manufacturing instructions and quality control procedures associated with the complaint were identified.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The device's design history files (dhf) were reviewed, and the risks associated with these devices are acceptable when weighed against the benefits.All tested devices met the acceptance criterion for verifying the catheter lumen is open.The lot number of the device is not known; accordingly, a review of the device history record could not be conducted.A database search for lots sold to the customer for the reported rpn over the past 3 years could not determine the affected lot for this complaint.At this time, there is no evidence of nonconforming product in house or in the field.The device is shipped with instruction for use (ifu) which provides the following information to the user related to the reported failure mode: precautions ¿if lumen flow is impeded, do not force injection or withdrawal of fluids.Notify attending physician immediately.¿ how supplied ¿upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the limited information provided, lack of lot number, and no device returned for investigation, a definitive cause could not be established.The appropriate internal personnel have been notified.Per the risk assessment, no further action is required.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 Description

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

• 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: 11874092
• MDR Text Key: 253037266
• Report Number: 1820334-2021-01389
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K033843
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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