MAUDE Adverse Event Report: COVIDIEN 5FR DUAL-LUMEN UVC CATH; CATHETER, UMBILICAL ARTERY

Model Number 8888160556

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pleural Effusion (2010); Pericardial Effusion (3271)

Event Date 04/16/2021

Event Type  Injury  

Manufacturer Narrative

The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.

Event Description

The customer reported an incident involving a (b)(6) old term baby.A 5f dual lumen umbilical vessel catheter (uvc) was placed at delivery on (b)(6) 2021 with no difficulty and good position.The uvc was secured by tape bridge.Tpn and pge were infusing.On (b)(6) 2021 at (b)(6) old, two fairly large pleural effusions of unknown etiology were discovered.The patient was emergently intubated and chest tubes were placed bilaterally that same day.A sample was obtained from the chest tubes and sent to the lab.The sample tested positive for extremely high glucose and triglycerides.That same day an echo was done and verified pericardial effusion so a pericardiocentesis was done and fluid was obtained from the pericardial space.This fluid was also sent off to lab and confirmed to have high levels of glucose and triglycerides.Both fluids were later determined to be tpn and lipids infusing through the uvc.The patient is currently in the icu.No further information is available.

• Brand Name: 5FR DUAL-LUMEN UVC CATH
• Type of Device: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): COVIDIEN; edificio b20 calle #2 zona fra; alajuela ; CS
• Manufacturer (Section G): COVIDIEN; edificio b20 calle #2 zona fra; alajuela ; CS
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 12051257
• MDR Text Key: 257798084
• Report Number: 3009211636-2021-00757
• Device Sequence Number: 1
• Product Code: FOS
• UDI-Device Identifier: 20884527005182
• UDI-Public: 20884527005182
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8888160556
• Device Catalogue Number: 8888160556
• Device Lot Number: 1916900048
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/28/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 1 DA