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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN 3.5FR DUAL-LUMEN UVC CATH CATHETER, UMBILICAL ARTERY

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COVIDIEN 3.5FR DUAL-LUMEN UVC CATH CATHETER, UMBILICAL ARTERY Back to Search Results
Model Number 8888160531
Device Problem Improper Flow or Infusion (2954)
Patient Problem No Known Impact Or Consequence To Patient (2692)
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
The customer reported that when administering the heparin through the line, it would not flush when prepping the patient.
 
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Brand Name3.5FR DUAL-LUMEN UVC 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 Key9775881
MDR Text Key193684664
Report Number3009211636-2020-00690
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 company representative,consum
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/21/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8888160531
Device Catalogue Number8888160531
Device Lot Number1905700096
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 Received02/26/2020
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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