MAUDE Adverse Event Report: COVIDIEN ***UVC TRAY/3.5FR PU; UMBILICAL VESSEL CATHETER

Model Number 8888160424

Device Problems Fluid/Blood Leak (1250); Connection Problem (2900); Improper Flow or Infusion (2954)

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

Event Date 11/28/2016

Event Type  malfunction  

Manufacturer Narrative

Submit date: 01/29/2017.An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2017 that an issue occurred with a umbilical vessel catheter.The customer states the patient had an uac (umbilical artery catheter) placed outside the facility prior to transfer to hospital with an infusion ruining.Rn noticed some slight back flow in the catheter and then noticed the catheter was wet.After drying the catheter to watch infusion and determine where fluid leak was occurring, it was determined that at the connection between the line and the connection hub was the location of the leak.Uac was then removed from patient due to leak and risk for infection.

Manufacturer Narrative

Submit date: 01/30/2017.

• 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: edward almeida ; 15 hampshire st; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6285546
• MDR Text Key: 66336152
• Report Number: 3009211636-2017-00063
• 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: health professional,other,use
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888160424
• Device Catalogue Number: 8888160424
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/30/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1