MAUDE Adverse Event Report: COVIDIEN 3.5FR URETHANE UMB CATH; UMBILICAL VESSEL CATHETER

Model Number 8888160333

Device Problems Backflow (1064); Fluid/Blood Leak (1250)

Patient Problem No Information (3190)

Event Date 10/25/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).An investigation is currently underway.Upon completion, the results will be forwarded.Several attempts to gather information from the customer were made.To date, no response has been received.If additional pertinent information becomes available, the report will be updated.

Event Description

It was reported to covidien on (b)(6) 2016 that a customer had an issue with an umbilical vessel catheter (uvc).The customer states that upon line change at 2020, the rn noted that the uac was leaking directly below the hub.Blood was backing up the line.The peds surg team was paged.Doctors in to assess.The line was repaired successfully per policy.Fluids restarted at 2145, waveform optimal.

Manufacturer Narrative

Please disregard this report number 3009211636-2016-00068 as it was generated in error.This is a duplicate of mfr report# 3009211636-2015-00202.Based on discovery of the duplication, this file will be closed and the complaint record voided.

• Brand Name: 3.5FR URETHANE UMB CATH
• Type of Device: UMBILICAL VESSEL CATHETER
• Manufacturer (Section D): COVIDIEN; covidien manufacturing solutions sa; edificio 820 calle #2 zona france coyol; alajuela ; CS
• Manufacturer (Section G): COVIDIEN; covidien manufacturing solutions sa; edificio 820 calle #2 zona france coyol; alajuela ; CS
• Manufacturer Contact: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5409991
• MDR Text Key: 38095829
• Report Number: 3009211636-2016-00068
• 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: other
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888160333
• Device Catalogue Number: 8888160333
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1