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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 03/22/2017
Event Type  malfunction  
Manufacturer Narrative
Submit date: 05/01/2017.An investigation is currently underway.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 reported that there is leaking from the catheter.The catheter was removed and replaced with a new one.
 
Manufacturer Narrative
An investigation was performed.This complaint has not been confirmed.The actual sample involved in the reported condition was not returned for evaluations.No additional information, pictures or videos were received.Since no sample was returned for examination, it was not possible to evaluate it as part of a comprehensive reported condition investigation.As 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.If the sample is returned in the future, this complaint will be re-opened for further investigation.The available information was analyzed and it did not allow confirming a root cause for the event.However, a process failure mode effects analysis (pfmea) was reviewed in order to identify the possible causes for the reported condition.The following potential causes were identified in the pfmea/design failure mode and effect analysis (dfmea) indicates machine malfunction, customer misuse.A complaint history analysis was conducted.No trends or triggers have been found, therefo re, a corrective or preventive action is not deemed necessary at this time.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 sampli ng 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.
 
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Brand Name
ARGYLE
Type of Device
CATHETER, 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 Key6534145
MDR Text Key74089892
Report Number3009211636-2017-05098
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 user facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number8888160333
Device Catalogue Number8888160333
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 04/03/2017
Initial Date FDA Received05/01/2017
Supplement Dates Manufacturer Received04/03/2017
Supplement Dates FDA Received12/07/2017
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
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