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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 Material Puncture/Hole (1504)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
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 there was a hole in the tubing of the central line. There was no harm to 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
777 west street
mansfield, MA 02048
5086183640
MDR Report Key12438451
MDR Text Key270281967
Report Number3009211636-2021-00762
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,distri
Reporter Occupation
Type of Report Initial
Report Date 09/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8888160531
Device Catalogue Number8888160531
Device Lot Number2011900076
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/27/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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