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Model Number 8888160341
Device Problem Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/10/2017
Event Type  malfunction  
Manufacturer Narrative
Investigation was performed. This complaint has not been confirmed. The actual sample involved in the reported incident 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 investigation. As no lot number was identified, a manufacturing device history record (dhr) review for product/process changes for the involved lot number could not be performed. However, all dhrs are reviewed for accuracy prior to product release. The available information was analyzed and was inconclusive without a sample to evaluate therefore a root cause could not be identified for this complaint. Processes were reviewed in order to identify the possible causes for the possible condition of leaking: machine malfunction, unintentional customer misuse, product inspection inadequacy or not performed, or a sharp object was used that came into contact with the catheter are all possibilities. Sharp objects should not be used with a catheter. The complaint has not been identified as manufacturing related issues. No trends or triggers have been found, 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 plan 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: 05/19/2017. 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 reports immediately after the uvc (umbilical vessel catheter) was placed, a leak was detected just below the hub/butterfly where the catheter is joined. The customer further reports that the leak was discovered when the bedside rn was drawing labs from the catheter. The uvc was not in use yet and was removed and replaced with a new one.
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Brand NameARGYLE
Manufacturer (Section D)
edificio b20, calle #2
alajuela 0101
Manufacturer (Section G)
edificio b20, calle #2
alajuela 0101
Manufacturer Contact
edward almeida
15 hampshire street
mansfield, MA 02048
MDR Report Key6577926
MDR Text Key246988147
Report Number3009211636-2017-05113
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,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/26/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/19/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8888160341
Device Catalogue Number8888160341
Device Lot NumberUNKNOWN
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 Received04/27/2017
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown