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

Model Number 8888160556

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Date submitted: (b)(6) 2019.The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.

Event Description

The customer reported the rn was attempting to flush the umbilical vessel catheter's #2 distal lumen with heparin.When the syringe plunger was pressed into the distal lumen port, fluid began to be pressed backward through the proximal lumen.The fluid leaked out at the bifurcation point of the proximal and distal lumens.After further examination, it was discovered that the proximal lumen had snapped and disconnected from the extended line.The provider was notified, fluid was discontinued, and the line was clamped and removed.New fluid was started through a peripheral iv.Another line was attempted unsuccessfully and nutrition was continued through the peripheral iv.

• 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 ; 15 hampshire street; mansfield, MA 02048 ; 5084524970
• MDR Report Key: 8274264
• MDR Text Key: 134064140
• Report Number: 3009211636-2019-00638
• Device Sequence Number: 1
• Product Code: FOS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8888160556
• Device Catalogue Number: 8888160556
• Device Lot Number: 1807300140
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/27/2018
• Initial Date FDA Received: 01/24/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1