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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN ARGYLE CATHETER, UMBILICAL ARTERY

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COVIDIEN ARGYLE CATHETER, UMBILICAL ARTERY Back to Search Results
Model Number 8888160333
Device Problem Leak/Splash (1354)
Patient Problem No Patient Involvement (2645)
Event Date 04/14/2017
Event Type  malfunction  
Manufacturer Narrative
Submit date: 05/12/17. An investigation is currently under way; upon completion the results will be forwarded. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
The customer states the product is cracking and leaking. This was discovered during testing.
 
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Brand NameARGYLE
Type of DeviceCATHETER, UMBILICAL ARTERY
Manufacturer (Section D)
COVIDIEN
edificio b20, calle #2
alajuela 0101
Manufacturer (Section G)
COVIDIEN
edificio b20, calle #2
alajuela 0101
Manufacturer Contact
edward almeida
15 hampshire street
mansfield, MA 02048
5084524151
MDR Report Key6563469
MDR Text Key75039184
Report Number3009211636-2017-05107
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,user f
Reporter Occupation
Type of Report Initial
Report Date 04/14/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/12/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8888160333
Device Catalogue Number8888160333
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/14/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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