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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDINAL HEALTH 3.5FR URETHANE UMB CATH CATHETER, UMBILICAL ARTERY

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CARDINAL HEALTH 3.5FR URETHANE UMB CATH CATHETER, UMBILICAL ARTERY Back to Search Results
Model Number 8888160333
Device Problem Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Submit date: 08/14/2018. The incident device 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. As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
 
Event Description
The customer stated that when they clamp the line just outside of the connector, they experience the line breaking or splitting. They clamp the line to avoid blood back flow. There is no known consequence or impact to the patient.
 
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Brand Name3.5FR URETHANE UMB CATH
Type of DeviceCATHETER, UMBILICAL ARTERY
Manufacturer (Section D)
CARDINAL HEALTH
edificio b20 calle #2 zona fra
alajuela
CS
Manufacturer (Section G)
COVIDIEN
edificio b20 calle #2 zona fra
alajuela
CS
Manufacturer Contact
edward almeida
15 hampshire street
mansfield, MA 02048
5084524151
MDR Report Key7783205
MDR Text Key117142215
Report Number3009211636-2018-00600
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 user facility
Reporter Occupation
Type of Report Initial
Report Date 08/14/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/14/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8888160333
Device Catalogue Number8888160333
Device Lot Number1722800080
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/26/2018
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 Unkown

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