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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 Problems Complete Blockage (1094); Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/06/2020
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
The customer reported blood backing up in the uvc. The transport nurse was at the bedside to troubleshoot. The infusion rate of d10w with heparin was increased to try to clear line (tkvo prior). Then the bed was observed to be wet and leaking of solution visible from upper part of uvc line a few centimeters below the clave. No patient injury was reported.
 
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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 Key11269830
MDR Text Key230010897
Report Number3009211636-2021-00733
Device Sequence Number1
Product Code FOS
UDI-Device Identifier20884527005120
UDI-Public20884527005120
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 02/02/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/02/2021
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 Received01/26/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/06/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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