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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 8888160424
Device Problem Leak/Splash (1354)
Patient Problem No Information (3190)
Event Date 06/17/2017
Event Type  malfunction  
Manufacturer Narrative
A device history record (dhr) review revealed no discrepancies that may have contributed to a complaint of this reported issue. All quality assurance testing performed during manufacturing was acceptable. The quality assurance review of the visual, physical and dimensional evaluation results indicated that the product met specification requirements. In addition, all dhr 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 product for the reported condition as part of a comprehensive failure investigation. No probable cause was found since no sample, picture¿s or video were received for testing, therefore the reported condition is not confirmed. If the sample is returned in the future, this complaint will be re-opened for further investigation. Potential failure could occur during normal use if there is a leak at the strain relief junction however manufacturing performs a 100% leak testing as per procedure which would identify this issue during the catheter assembly. No trends or triggers have been identified therefore, 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 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: 09/12/2017. An investigation is currently underway. Upon completion, the results will be forwarded. (b)(4).
 
Event Description
The customer states umbilical venous catheter was placed in an infant. Immediately upon going to use the line, the nurse noticed that there was an issue. The line was leaking where line meets the hub. The device was removed immediately.
 
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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 Key6860629
MDR Text Key194264452
Report Number3009211636-2017-05292
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,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/09/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/12/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8888160424
Device Catalogue Number8888160424
Device Lot Number1708800127
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 Received07/13/2017
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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