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U.S. Department of Health and Human Services


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Model Number 8888160333
Device Problem Leak/Splash (1354)
Patient Problem No Information (3190)
Event Date 01/05/2018
Event Type  malfunction  
Manufacturer Narrative
A device history record (dhr) review revealed no discrepancies that may have contributed to a complaint of this reported condition. 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 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 reported condition is not confirmed. If the sample is returned in the future, this complaint will be re-opened for further investigation. The manufacturing process was reviewed for the condition of leakage as a potential failure. However, manufacturing performs 100% leak testing as per procedure which would identify this issue in the catheter assembly. It must be noted that in-process controls such as per sonnel 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: 02-08-2018. The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event. As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product. If additional information or the sample is received, the investigation will be reopened and responded to accordingly. If information is provided in the future, a supplemental report will be issued.
Event Description
The customer reports that during a procedure the umbilical vessel catheter (uvc) was leaking. The customer further reports that the hub was cracked.
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Brand NameARGYLE
Manufacturer (Section D)
edificio b20, calle #2
alajuela 20101
Manufacturer (Section G)
edificio b20, calle #2
alajuela 20101
Manufacturer Contact
edward almeida
15 hampshire street
mansfield, MA 02048
MDR Report Key7252936
MDR Text Key253304838
Report Number3009211636-2018-00039
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
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 Received02/08/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/02/2022
Device Model Number8888160333
Device Catalogue Number8888160333
Device Lot Number1703200083
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 Received01/09/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/02/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown