MAUDE Adverse Event Report: COOK INC TRIPLE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER TRAY; FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/09/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter occupation: supply chain coordinator.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, 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

It was reported that the catheter in a triple lumen polyurethane central venous catheter tray migrated.The device was placed in the patient's right internal jugular (ij) and was secured to the patient with suture and the moveable suture wing.Later, it was discovered that the catheter had migrated out of the patient; however, the moveable wing was still sutured to the patient.It was noted that the line always leans to the right and the patient was not moving their head.Additional information regarding the event and patient outcome 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 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

In additional information, it was reported that the patient did not have the central line replaced.However, the patient required peripheral intravenous (ivs) lines.It was noted the patient had prolonged hospitalization.

Event Description

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

Manufacturer Narrative

Investigation ¿ evaluation: a representative of (b)(6) hospital (united states) informed cook that on 09sep2022 the catheter in a triple lumen polyurethane central venous catheter tray ( c-utlmy-701j-cct-a-rd; lot unknown) fell out.The line was removed inadvertently even though the movable suture wing was still sutured to the patient.The patient was not moving their head back and forth.The patient always leaned to the right side where the line was.The central line catheter was not replaced, though it was reported the patient experienced prolonged hospitalization due to replacing the catheter with ivs.It was reported that there were no other adverse effects to the patient due to this incident.Reviews of the instructions for use (ifu) and quality control procedures of the device, as well as a visual inspection, functional test, and dimensional verification of the returned device, were conducted during the investigation.Cook received one used 7fr central venous catheter.Table top testing found the red cap felt secure and no movement on the catheter was detected.The outer diameter of the catheter was measured and found to be within specification.Additionally, 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.The customer did not provide the lot number for the complaint devices.Cook reviewed the sales history for this customer and was unable to identify the complaint lot.The device history record could not be reviewed.The information provided upon review of device master record 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.Cook also reviewed product labeling.The product ifu, [c_t_ctulm_rev6] ¿cook ventral venous catheter power injectable,¿ provides the following information to the user related to the reported failure mode: precautions ¿patient movement can cause catheter tip displacement.Use should be limited to controlled hospital situations.Catheters placed from either a jugular or subclavian vein have demonstrated forward tip movement of 1-3 cm with neck and shoulder motion.Instructions for use ¿9.¿ winged hub can now be sutured into place.If catheter is not introduced to its full length, additional suture should be carefully placed around catheter and affixed to the skin at entry site (if movable suture wing is not included).This will help prevent backward or forward catheter movement.¿ based on the information provided, inspection of the returned device, and the results of the investigation, cook concluded inherent risk of the device as a possible cause.It was not reported if the entire catheters length was placed in the patient.It is possible that the placement of the movable suture wing was not placed close enough to the entry site to prevent the backward or forward movement, but cook cannot confirm this.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.

• Brand Name: TRIPLE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER TRAY
• 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: 15491306
• MDR Text Key: 301084066
• Report Number: 1820334-2022-01541
• Device Sequence Number: 1
• Product Code: FOZ
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2022
• 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: C-UTLMY-701J-CCT-A-RD
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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