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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 Known Impact Or Consequence To Patient (2692)
Event Date 02/18/2017
Event Type  malfunction  
Manufacturer Narrative
Submit date: 1/12/2018. A device history record (dhr) review of the reported lot number confirmed that the product was produced accomplishing quality requirements and released according to established procedures. The actual sample involved in the reported incident was not returned for evaluation. No additional information, pictures or videos were received. Consequently, it was not possible to evaluate it as part of a comprehensive failure investigation. No probable cause was found since no sample, picture or video were received for testing, therefore the defect is not confirmed. If the sample is returned in the future, this complaint will be re-opened for further investigation. It must be noted that in-process controls (such as personnel training, incoming quality acceptance testing for raw material, 100% in process visual inspection and visual acceptance sampling are performed in the plant) are in place to prevent nonconforming product from leaving the manufacturing operations. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Submit date: 7/19/2017. 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 reports uvc leaking at the distal attachment to the inbuilt luer adapter and uvc tore at the connection of the luer lock.
 
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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 Key6726432
MDR Text Key258023876
Report Number3009211636-2017-05226
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 other
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/12/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/19/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/17/2021
Device Model Number8888160333
Device Catalogue Number8888160333
Device Lot Number1632100151
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/20/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/17/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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