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

Model Number G49804

Device Problems Entrapment of Device (1212); Device Markings/Labelling Problem (2911)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/08/2020

Event Type  Injury  

Event Description

There are 2 concerns regarding the device in question; 1st: the exterior labeling of cook medical's triple lumen 9fr vs 7fr appears the same. There are no exterior indications indicating a difference in size such as differing font or color as with most medical products. As the exterior is identical it is easy to get confused between the 2 sizes. The 7fr kit is the usual kit used and requested, however due to exterior product appearance can easily be confused. The 9fr kit, unlike the 7fr kit, includes a pre-assembled introducer inside of the catheter. When the provider requested a triple lumen kit the 7fr was intended but the 9fr was used. Second: the catheter has a small white label with small black font in multiple languages stating to "remove after catheter insertion". The concern is there is nothing bold pointing out the need to remove the introducer. Perhaps a different colored tag with larger writing would draw the eye better. The label was overlooked and the device used. There is also a luer lock at the end of the introducer which makes the user believe it is a necessary part of the device and also able to use it for blood return and flushing. The patient was transferred to another care area and the receiving team noted the introducer still in place approximately 1 hour after initial placement. The joint commission deemed this event sentinel for an unintended retained foreign object, and recommended this information be submitted to the fda for awareness. A notification to the manufacturer already took place. Fda safety report id# (b)(4).

• Brand Name: CENTRAL VENOUS TRAY TRIPLE LUMEN
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COOK, INC.
• MDR Report Key: 9952857
• MDR Text Key: 187747987
• Report Number: MW5094102
• 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: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/08/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: G49804
• Device Catalogue Number: C-UTLMY-701J-RSC-ABRM-HC-IHI-FST-A-RD
• Device Lot Number: 8873615
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient Treatment Data

Date Received: 04/10/2020 Patient Sequence Number: 1