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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 Fluid Leak (1250)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/14/2021
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. As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
 
Event Description
Customer reports: the device was leaking at the junction between the hub and tubing during use on a patient. The device began leaking approximately 20 minutes into use. There were three incidents that occurred with the same batch within the time period of april 2021 through may 2021.
 
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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)
CARDINAL HEALTH
edificio b20 calle #2 zona fra
alajuela
CS
Manufacturer Contact
jill saraiva
15 hampshire street
mansfield, MA 02048
5086183640
MDR Report Key11962747
MDR Text Key258412293
Report Number3009211636-2021-00751
Device Sequence Number1
Product Code FOS
Combination Product (y/n)N
Reporter Country CodeHK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number8888160333
Device Catalogue Number8888160333
Device Lot Number1829700083
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Date Manufacturer Received05/20/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage

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