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

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Type  Injury  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.D1 - brand name: cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter set.E3- occupation: materials management admin.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 a catheter from a cook¿s spectrum minocycline/rifampin impregnated triple lumen central venous catheter tray leaked.The device was placed in the patient on (b)(6) 2024.On (b)(6) 2024, leakage at the hub connection was discovered.The complaint device was then removed and replaced.The patient experienced a decreased blood pressure until the device was replaced.No other adverse effects were reported for this incident.

• 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: 18546472
• MDR Text Key: 333280127
• Report Number: 1820334-2024-00091
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00827002349148
• UDI-Public: (01)00827002349148(17)251231(10)15496527
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/19/2024

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: C-UTLMY-701J-ABRM-CUSTOM-0042
• Device Lot Number: 15496527
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/11/2024
• Initial Date FDA Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2023
• 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