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

Model Number N/A

Device Problem Leak/Splash (1354)

Patient Problem Sepsis (2067)

Event Date 10/28/2020

Event Type  Injury  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.D2- these fields are unavailable for this device as the identity of the device is currently unknown.However, the product code foz has been selected based on available information.E1 - customer (person): postal code: 5000; phone: 004566113333.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 or that a death or serious injury occurred; nor is it admission 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 an unknown 3 french single lumen cook catheter leaked.The device was required for home parenteral nutrition administration.The device was placed via seldinger technique with use of x-ray in the left subclavian vein.The vein was located, the wire guide was successfully inserted, and the catheter was placed.Catheter flow was confirmed, then the lumen was locked with 15 iu of heparin.The procedure was successfully completed.Later, leakage from the infusion set was reported.Two blood cultures were taken, including a culture from the catheter.Methicillin resistant staphylococcus aureus (mrsa) and enterococcus cloacae were discovered in the culture and severe sepsis was diagnosed.No other adverse effects were reported for this incident.Additional information regarding the event and patient outcome has been requested but is currently unavailable.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: b5.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 or that a death or serious injury occurred; nor is it admission 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

Additional information was provided.As reported, the catheter was placed in "ga" with use of transillumination radiography.The vein on the left side was located; however the catheter was not placed on the left because the wire guide could not be inserted.The vein on the right side was then located, and the catheter was successfully placed in the right subclavian vein with the tip in the heart atrium.Later, leakage at the insertion site used for home parenteral nutrition was identified.

Manufacturer Narrative

Correction: this report is being sent to indicate the event does not meet the criteria of a reportable complaint on a cook device.Cook made multiple attempts to obtain product identity information from the customer.On 01mar2024, the customer indicated that since the event occurred, they have a new medical record system and do not have the requested information to confirm product identity.However, the customer provided photos and videos of the complaint device.Cook reviewed the images and determined the complaint device was not a cook product.Therefore, based on provided information, there is no alleged deficiency related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a cook device.This event will be close/cancelled by cook.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 or that a death or serious injury occurred; nor is it admission 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

This event no longer meets the qualifications for a reportable event.See h10.

• 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: 18319308
• MDR Text Key: 330390697
• Report Number: 1820334-2023-01694
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/07/2024

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 Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/07/2023
• Initial Date FDA Received: 12/13/2023
• Supplement Dates Manufacturer Received: 12/20/2023; 03/01/2024
• Supplement Dates FDA Received: 01/05/2024; 03/07/2024
• 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
• Patient Outcome(s): Life Threatening
• Patient Sex: Male