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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN 5.0FR URETHANE UMB CATH CATHETER, UMBILICAL ARTERY

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COVIDIEN 5.0FR URETHANE UMB CATH CATHETER, UMBILICAL ARTERY Back to Search Results
Model Number 8888160341
Device Problem Fluid Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/11/2020
Event Type  malfunction  
Manufacturer Narrative
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.
 
Event Description
Customer reports that the device malfunctioned during use on a premature newborn baby. The device was working but "has stopped reading well" due to a leakage. On 1/8/2021 additional information states: the uac stopped reading well, so the line was inspected. Blood was noted to be backing up into catheter so all clamps were checked and verified fluid was infusing. The uac was flushed and noted there was a leak in the line where it connects to the hub. The uac was clamped below the leak, but per md had to be left in until off the ecmo circuit, which wasn't cut away until the end of the shift. This resulted in the loss of an arterial line for an ecmo trial and cut away, and left no drawable lines for gases resulting in pokes of a heparinized infant.
 
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Brand Name5.0FR URETHANE UMB CATH
Type of DeviceCATHETER, 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
5086183640
MDR Report Key11143328
MDR Text Key226030823
Report Number3009211636-2021-00732
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,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/15/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8888160341
Device Catalogue Number8888160341
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/07/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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