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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 10/28/2016
Event Type  malfunction  
Manufacturer Narrative
Submit date: 4/4/2018. Since no lot number was identified, a manufacturing device history review (dhr) or product/process changes review for the involved lot number could not be performed. However, all dhrs are reviewed for accuracy prior to product release. 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. This complaint will be used for tracking and trending purposes. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Submit date: 6/28/17. An investigation is currently under way; upon completion the results will be forwarded.
 
Event Description
The customer reports the umbilical line has a hole in it.
 
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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 Key6673184
MDR Text Key254673271
Report Number3009211636-2017-05212
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,Followup
Report Date 04/04/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/28/2017
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? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/01/2017
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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