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U.S. Department of Health and Human Services

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

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COVIDIEN ***UVC TRAY/3.5FR PU UMBILICAL VESSEL CATHETER Back to Search Results
Model Number 8888160424
Device Problems Fluid 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.
 
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Type of DeviceUMBILICAL 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 Key6285546
MDR Text Key66336152
Report Number3009211636-2017-00063
Device Sequence Number1
Product Code FOS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/12/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/30/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8888160424
Device Catalogue Number8888160424
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/30/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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