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Model Number 8888160333
Device Problem Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/08/2017
Event Type  malfunction  
Manufacturer Narrative
A device history 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 samples, 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. Manufacturing performs 100% leak testing as per procedure which would identify this issue in the catheter assembly. 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 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: 10/24/17. An investigation is currently under way; upon completion the results will be forwarded. If information is provided in the future, a supplemental report will be issued.
Event Description
The customer reported the following complaint regarding an infant delivered at 28 weeks and 6 days: the patient was stabilized with cpap initiation. An umbilical arterial (uac) and venous (uvc) catheters were inserted at delivery. The uac was a 3. 5 fr. Single lumen inserted by the neonatal nurse practitioner (nnp). Approximately 1 hour after insertion and approximately 10 minutes after starting a premasol infusion, the uac was noted to be leaking from a hole at the end near the hub. On inspection, the np noted a "crack" in the catheter. The line was clamped and then removed.
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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 Key6973975
MDR Text Key258437185
Report Number3009211636-2017-05335
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 health professional,other,use
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/18/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/24/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8888160333
Device Catalogue Number8888160333
Device Lot Number1715200155
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 Received10/12/2017
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 Initial