MAUDE Adverse Event Report: COOK INC; Catheter, intravascular, therapeutic, short-term less than 30 days

Model Number N/A

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504); Material Split, Cut or Torn (4008)

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

Event Date 10/20/2021

Event Type  Injury  

Event Description

It was reported that a hole was observed in the middle blue lumen hub of a cook triple lumen femoral line placed in a picu patient.This hole was visible when the line was flushed.Additional information regarding event and patient 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.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Additional information: b5, h6 - annex e, h6 - annex f; 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

In additional information received on 28feb2022, it was reported that the central line had already been placed in the patient when the hole was discovered.As a result, the line was removed and replaced with a new device.It was confirmed that the device was secured to the patient, however the method of securement is unknown.No unintended section of the device remained in the patient.No hospitalization or prolonged hospitalization was required due to this occurrence.

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 unknown, unavailable, or unchanged.Correction: h6 - annex a.Investigation ¿ evaluation.On 14feb2022 carilion roanoke memorial hospital (united states) informed cook of a cook triple lumen femoral line of an unknown rpn and unknown lot number with a crack in the middle of the blue lumen hub placed in a picu patient on 20oct2021.It was reported that the central line had already been placed in the patient when the crack was discovered.This crack was visible when the line was flushed.Another procedure was required to replace the line with a new device.It was confirmed that the device was secured to the patient, however the method of securement is unknown.It was reported that there were no adverse effects due to this occurrence.No unintended section of the device remained in the patient.No hospitalization or prolonged hospitalization was required due to this occurrence.A review of instructions for use (ifu), quality control procedures, and other documentation, as well as a visual inspection and functional test, were conducted during the investigation.One used 7fr cvc with a crack on the blue batwing hub was returned to cook.During the leak test the blue hub leaked through the crack.Additionally, a document-based investigation evaluation was performed.The customer did not provide a rpn.Based on the sales to this customer, cook will base the device master record on rpn c-utlmy-701j-abrm-custom-0017.A review of the device master record (dmr) 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.Based on the available information, cook has concluded that the device was manufactured to specification and that there is no evidence suggesting nonconforming product exists either in house or in 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: how supplied: ¿-upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the information provided, inspection of the returned device, and the results of the investigation, cook concluded the main cause of failure was design-related.Appropriate measures have been taken to address this failure mode.A capa was previously opened to further investigate this failure mode.Corrective actions have since been implemented following the manufacture of this device.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the risk assessment no further action is required.Appropriate measures have been taken to address this failure mode.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.

• Type of Device: 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: 13636397
• MDR Text Key: 289109743
• Report Number: 1820334-2022-00321
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/29/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 17 YR
• Patient Sex: Male